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Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).

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ClinicalTrials.gov Identifier: NCT02475733
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Complicated Intra-abdominal Infections
Interventions Drug: Ceftazidime -avibactam
Drug: Meropenem
Drug: Metronidazole
Enrollment 83
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion. Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Period Title: Overall Study
Started 61 22
Completed 59 22
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Physician Decision             1             0
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem Total
Hide Arm/Group Description Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion. Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion. Total of all reporting groups
Overall Number of Baseline Participants 61 22 83
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) analysis set included all participants who had been assigned a randomized treatment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 61 participants 22 participants 83 participants
10.4  (3.64) 9.7  (3.97) 10.2  (3.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 22 participants 83 participants
Female
17
  27.9%
13
  59.1%
30
  36.1%
Male
44
  72.1%
9
  40.9%
53
  63.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 22 participants 83 participants
Hispanic or Latino
12
  19.7%
1
   4.5%
13
  15.7%
Not Hispanic or Latino
49
  80.3%
21
  95.5%
70
  84.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 61 participants 22 participants 83 participants
American Indian or Alaska Native
1
   1.6%
0
   0.0%
1
   1.2%
Asian
7
  11.5%
4
  18.2%
11
  13.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
53
  86.9%
16
  72.7%
69
  83.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
2
   9.1%
2
   2.4%
1.Primary Outcome
Title Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between first dose of study drug and up to late follow-up (LFU) visit (20 to 35 days after last dose of study treatment [IV or oral]) that were absent before treatment or that worsened relative to pretreatment state. AEs included both SAE and non-SAE.
Time Frame Baseline until the LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
AEs 52.5 59.1
SAEs 8.2 4.5
2.Primary Outcome
Title Percentage of Participants With Cephalosporin Class Effects and Additional Adverse Events (AEs)
Hide Description Percentage of participants with Cephalosporin class effects (defined as adverse event of special interest (AEoSI) within the safety topics (ST) of hypersensitivity/anaphylaxis) and additional AEs (which included AEs of seizures, diarrhea, renal disorder, and liver disorder relevant to the cephalosporin class within the ST and AEs with preferred term in the system organ class of nervous system disorder system organ class based on MedDRA 20.0) were reported in this outcome measure.
Time Frame Baseline until the LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
AE in the ST of Diarrhea 1.6 0
AEoSI in the ST of Hypersensitivity/Anaphylaxis 4.9 13.6
AE in the ST of Liver Disorder 0 0
AE in the ST of Renal Disorder 0 0
AEs with PTs in the Nervous System Disorder SOC 1.6 4.5
AE of seizure 0 0
3.Primary Outcome
Title Change From Baseline in Pulse Rate at End of Intravenous Therapy (EOIV) Visit
Hide Description EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame Baseline, EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Mean (Standard Deviation)
Unit of Measure: beats per minute
Baseline Number Analyzed 61 participants 22 participants
102.1  (17.07) 103.0  (23.31)
Change at EOIV Number Analyzed 60 participants 22 participants
-15.2  (20.45) -15.4  (21.74)
4.Primary Outcome
Title Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at End of Intravenous Therapy (EOIV) Visit
Hide Description EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame Baseline, EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Mean (Standard Deviation)
Unit of Measure: millimeter of mercury (mmHg)
SBP: Baseline Number Analyzed 60 participants 22 participants
109.7  (13.90) 111.6  (13.06)
SBP: Change at EOIV Number Analyzed 59 participants 22 participants
-4.0  (12.32) -6.0  (13.66)
DBP: Baseline Number Analyzed 60 participants 22 participants
63.5  (10.36) 63.1  (13.51)
DBP: Change at EOIV Number Analyzed 59 participants 22 participants
1.3  (11.99) -2.8  (14.14)
5.Primary Outcome
Title Change From Baseline in Respiratory Rate at End of Intravenous Therapy (EOIV) Visit
Hide Description EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame Baseline, EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Mean (Standard Deviation)
Unit of Measure: breaths per minute
Baseline Number Analyzed 58 participants 21 participants
22.4  (5.02) 22.9  (5.79)
Change at EOIV Number Analyzed 56 participants 21 participants
-1.3  (4.57) -1.3  (4.44)
6.Primary Outcome
Title Change From Baseline in Body Weight at End of Intravenous Therapy (EOIV) Visit
Hide Description EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame Baseline, EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Mean (Standard Deviation)
Unit of Measure: kilograms
Baseline Number Analyzed 61 participants 22 participants
40.58  (16.286) 38.35  (16.685)
Change at EOIV Number Analyzed 56 participants 20 participants
-0.38  (1.442) -1.06  (1.490)
7.Primary Outcome
Title Change From Baseline in Body Temperature at End of Intravenous Therapy (EOIV) Visit
Hide Description EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame Baseline, EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Mean (Standard Deviation)
Unit of Measure: degree Celsius
Baseline Number Analyzed 60 participants 22 participants
37.35  (1.035) 37.16  (0.914)
Change at EOIV Number Analyzed 59 participants 22 participants
-0.78  (0.987) -0.60  (0.780)
8.Primary Outcome
Title Percentage of Participants With Abnormal Physical Examination Findings at End of Intravenous Therapy (EOIV) Visit
Hide Description Physical examination included an assessment of the following: general appearance, skin, head and neck (including ears, eyes, nose and throat), lymph nodes, thyroid, respiratory system, cardiovascular system, abdomen, musculoskeletal system (including spine and extremities), and neurological system. Participants with new or aggravated abnormal physical examination findings with regard to baseline findings were reported. Abnormality in physical examinations were based on blinded observer’s discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
Abdomen 6.6 18.2
Cardiovascular System 0 0
General Appearance 1.6 0
Head and Neck 0 0
Lymph Nodes 0 0
Musculoskeletal System 0 0
Neurological System 0 0
Respiratory System 3.3 0
Skin 1.6 0
Thyroid 0 0
9.Primary Outcome
Title Percentage of Participants With Potentially Clinically Significant Abnormalities in Laboratory Parameters
Hide Description Criteria for potentially clinically significant laboratory abnormalities: Chemistry (calcium: <0.7*lower limit of normal range [LLN] and >30 percent decrease from baseline [DFB]; alanine aminotransferase [ALT]: >3*upper limit of normal range [ULN] and >300 percent IFB; alanine aminotransferase [AST]: >3*ULN and >300 percent IFB) and hematology (platelets: >2*ULN and >100 percent IFB). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).
Time Frame Baseline until the LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
Chemistry: Calcium Number Analyzed 53 participants 21 participants
1.9 0
Chemistry: ALT Number Analyzed 59 participants 22 participants
1.7 0
Chemistry: AST Number Analyzed 55 participants 21 participants
1.8 0
Hematology: Platelets Number Analyzed 60 participants 22 participants
3.3 0
10.Primary Outcome
Title Percentage of Participants With Electrocardiogram (ECG) Parameter QTcF: > 450, >480 and >500 Millisecond (ms)
Hide Description ECG parameters included maximum QT intervals using Fridericia’s correction (QTcF). Maximum QTcF >450 millisecond (ms); maximum QTcF >480 ms; and maximum QTcF >500 ms. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame Baseline until the EOIV visit (anytime from Day 4 to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
Maximum QTcF Interval : >450 ms 1.6 4.5
Maximum QTcF Interval : >480 ms 1.6 4.5
Maximum QTcF Interval : >500 ms 0 4.5
11.Primary Outcome
Title Percentage of Participants With Creatinine Clearance (CrCl) at Day 7
Hide Description CrCl is a measure of glomerular filtration rate (GMFR), an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
CrCl: <30mL/min/1.73 m^2 0 0
CrCl: >=30 to <50mL/min/1.73 m^2 0 0
CrCl: >=50 to <80mL/min/1.73 m^2 0 0
CrCl: >=80mL/min/1.73 m^2 50.8 59.1
12.Primary Outcome
Title Percentage of Participants With Creatinine Clearance (CrCl) at End of Intravenous Therapy (EOIV) Visit
Hide Description CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
CrCl: <30mL/min/1.73 m^2 0 0
CrCl: >=30 to <50mL/min/1.73 m^2 0 0
CrCl: >=50 to <80mL/min/1.73 m^2 0 0
CrCl: >=80mL/min/1.73 m^2 82.0 81.8
13.Primary Outcome
Title Percentage of Participants With Creatinine Clearance (CrCl) at Test of Cure (TOC) Visit
Hide Description CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).
Time Frame TOC visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication (CAZ-AVI plus Metronidazole or Meropenem).
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
CrCl: <30mL/min/1.73 m^2 0 0
CrCl: >=30 to <50mL/min/1.73 m^2 0 0
CrCl: >=50 to <80mL/min/1.73 m^2 3.3 0
CrCl: >=80mL/min/1.73 m^2 42.6 59.1
14.Primary Outcome
Title Percentage of Participants With Creatinine Clearance (CrCl) at Late Follow-up (LFU) Visit
Hide Description CrCl is a measure of GMFR, an index of kidney function. It is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Percentage of participants with CrCl in the following categories were reported: <30 mL/min/1.73 m^2, >=30 to <50 mL/min/1.73 m^2, >=50 mL/min/1.73 m^2 to <80 mL/min/1.73 m^2, and >=80 mL/min/1.73 m^2. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).
Time Frame LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all randomized participants who received any amount of IV study medication.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Unit of Measure: percentage of participants
CrCl: <30mL/min/1.73 m^2 0 0
CrCl: >=30 to <50mL/min/1.73 m^2 0 0
CrCl: >=50 to <80mL/min/1.73 m^2 1.6 0
CrCl: >=80mL/min/1.73 m^2 6.6 9.1
15.Secondary Outcome
Title Plasma Concentrations of Ceftazidime and Avibactam
Hide Description [Not Specified]
Time Frame 15, 30-90, 300-360 minutes post-dose on Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all randomized participants who received any amount of study medication and had at least 1 CAZ and/ or AVI plasma measurement available. This outcome measure was not planned to be analyzed for meropenem receiving cohorts, as pre-specified in protocol.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Overall Number of Participants Analyzed 60
Geometric Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter
Ceftazidime: 15 minute post-dose on Day 3 Number Analyzed 59 participants
63565.5  (236761.80)
Ceftazidime: 30-90 minute post-dose on Day 3 Number Analyzed 60 participants
38048.0  (19810.95)
Ceftazidime:300-360minute post-dose on Day 3 Number Analyzed 60 participants
4603.0  (10308.96)
Avibactam: 15 minute post-dose on Day 3 Number Analyzed 59 participants
12186.2  (55720.44)
Avibactam: 30-90 minute post-dose on Day 3 Number Analyzed 60 participants
6548.6  (4437.55)
Avibactam: 300-360 minute post-dose on Day 3 Number Analyzed 60 participants
821.5  (1968.21)
16.Secondary Outcome
Title Percentage of Participants With Favorable Clinical Response (CR) at End of 72 Hours Treatment: Intent-to-treat (ITT) Analysis Population
Hide Description Favorable CR was defined as resolution of all acute signs and symptoms of complicated intra- abdominal infection (cIAIs), or improvement to such an extent that no further antimicrobial therapy was required, or improvement but not enough to switch to oral therapy and still on IV study drug at end of 72 hours and had met following criterion: absence of new signs and symptoms, improvement in at least 1 symptom/sign (fever, pain, tenderness, elevated White Blood Cells [WBCs], elevated c-reactive protein) from baseline and no worsening symptom/sign.
Time Frame End of 72 hours study drug treatment on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all participants who had been assigned a randomized treatment.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
93.4
(85.2 to 97.7)
90.9
(73.9 to 98.1)
17.Secondary Outcome
Title Percentage of Participants With Favorable Clinical Response (CR) at End of Intravenous Therapy (EOIV) Visit: Intent-to-treat (ITT) Analysis Population
Hide Description Favorable CR was resolution of all acute signs and symptoms of cIAI or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug.
Time Frame EOIV visit (anytime from Day 4 up to 16)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all participants who had been assigned a randomized treatment.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.7
(89.9 to 99.3)
100
(89.3 to 100)
18.Secondary Outcome
Title Percentage of Participants With Favorable Clinical Response (CR) at End of Treatment (EOT) Visit: Intent-to-treat (ITT) Analysis Population
Hide Description Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. EOT visit occurred within 48 hours after completion of the last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy).
Time Frame EOT visit (up to Day 17)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all participants who had been assigned a randomized treatment.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.8
(83.0 to 96.8)
100
(89.3 to 100)
19.Secondary Outcome
Title Percentage of Participants With Favorable Clinical Response (CR) at Test of Cure (TOC) Visit: Intent-to-treat (ITT) Analysis Population
Hide Description Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).
Time Frame TOC visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis population included all participants who had been assigned a randomized treatment.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 61 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
91.8
(83.0 to 96.8)
95.5
(80.7 to 99.5)
20.Secondary Outcome
Title Percentage of Participants With Favorable Clinical Response (CR): Clinically Evaluable (CE) Analysis Population
Hide Description Favorable CR was resolution of all acute signs and symptoms of cIAI, or improvement to such an extent that no further antimicrobial therapy was required, or improvement in participants who had switch to oral therapy and met the following criterion: afebrile (temperature <=38.0°C) for at least 24 hours, absence of new and improvement in at least 1 symptom or sign (fever, pain, tenderness, elevated WBCs, elevated c-reative-protein) from baseline and worsening of none. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study (if on oral switch therapy). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral).
Time Frame End of 72 hours study drug treatment on Day 1, EOIV (anytime from Day 4 up to 16), EOT visit (up to Day 17) and TOC visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
CE analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable clinicial response.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 56 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
End 72 hours study medication Number Analyzed 49 participants 20 participants
98.0
(90.9 to 99.8)
95.0
(78.9 to 99.5)
EOIV Number Analyzed 54 participants 20 participants
98.1
(91.7 to 99.8)
100
(88.3 to 100)
EOT Number Analyzed 52 participants 20 participants
94.2
(85.4 to 98.3)
100
(88.3 to 100)
TOC Number Analyzed 56 participants 20 participants
92.9
(83.9 to 97.5)
95.0
(78.9 to 99.5)
21.Secondary Outcome
Title Percentage of Participants With Favorable Microbiological Response: Microbiological Intent-to-treat (Micro-ITT) Population
Hide Description Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). EOIV visit occurred within 24 hours after completion of last infusion of the study drug. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).
Time Frame EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 50 19
Measure Type: Number
Unit of Measure: percentage of participants
EOIV 96.0 100
EOT 90.0 100
TOC 90.0 94.7
LFU 90.0 94.7
22.Secondary Outcome
Title Percentage of Participants With Favorable Microbiological Response: Microbiologically Evaluable (ME) Population
Hide Description Favorable microbiological response was achieved when all baseline pathogens were eradicated or presumed eradicated based on investigator's discretion. EOIV visit occurred within 24 hours after completion of last infusion of the study drug. EOT visit occurred within 48 hours after completion of last dose of oral switch therapy or at time of premature discontinuation/early withdrawal from study if on oral switch therapy (which occurred within the maximum study treatment duration of 15 days). TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).
Time Frame EOIV visit (Day 4 up to 16), EOT visit (up to Day 17), TOC visit (up to a maximum study duration of 50 days) and LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ME analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable microbiological response.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 40 15
Measure Type: Number
Unit of Measure: percentage of participants
EOIV Number Analyzed 40 participants 15 participants
97.5 100
EOT Number Analyzed 36 participants 15 participants
91.7 100
TOC Number Analyzed 40 participants 15 participants
90.0 93.3
LFU Number Analyzed 37 participants 14 participants
89.2 92.9
23.Secondary Outcome
Title Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Clinically Evaluable (CE) Population
Hide Description A participant was said to have clinical relapse if met either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).
Time Frame LFU visit (up to a maximum study duration of 50 days)
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Hide Analysis Population Description
CE analysis population included randomized participants with cIAI who received study medication for >=48h and clinical failure or clinical failure with treatment limiting AE and participants with >=72h treatment and favorable clinicial response. Here, number of participants analyzed=participants who were evaluable for this measure.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 48 18
Measure Type: Number
Unit of Measure: percentage of participants
0 0
24.Secondary Outcome
Title Percentage of Participants With Clinical Relapse at Late Follow-up (LFU) Visit: Microbiologically Evaluable (ME) Population
Hide Description A participant was said to have clinical relapse if me either 1 of the following criteria: reappearance or worsening of signs and symptoms of cIAI that required further antimicrobial therapy and/or surgery, or death after TOC in which cIAI was contributory. LFU visit occurred within 20 to 35 days after last dose of study treatment (IV or oral).
Time Frame LFU visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ME analysis population included randomized participants with cIAI who received study medication for >=48 h and clinical failure or clinical failure with treatment limiting AE and participants with >=72 h treatment and favorable microbiological response. Here, number of participants analyzed=participants who were evaluable for this measure.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 37 14
Measure Type: Number
Unit of Measure: percentage of participants
0 0
25.Secondary Outcome
Title Percentage of Participants With Emergent Infections: Microbiological Intent-to-treat (Micro-ITT) Population
Hide Description Emergent infections were categorized as super infections and new infections. Superinfection: An intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. New infection: An intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment had finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. Participants with any (super infections or new infections) of the infections were reported.
Time Frame Baseline up to 50 days
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Hide Analysis Population Description
Micro-ITT analysis population included all randomized participants who had a baseline pathogen known to cause cIAI.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 50 19
Measure Type: Number
Unit of Measure: percentage of participants
0 0
26.Secondary Outcome
Title Percentage of Participants With Emergent Infections at Test of Cure (TOC) Visit: Microbiologically Evaluable Population
Hide Description Emergent Infections was an intra-abdominal culture identified pathogen other than a baseline pathogen during the course of active treatment with study therapy along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy, new infection was an intra-abdominal culture identified pathogen other than a baseline pathogen at any time after study treatment has finished along with worsening signs and symptoms of infection requiring alternative antimicrobial therapy. TOC visit occurred within 8 to 15 days after last dose of any study drug (IV or oral). Participants with any (super infections or new infections) of the infections were reported.
Time Frame TOC visit (up to a maximum study duration of 50 days)
Hide Outcome Measure Data
Hide Analysis Population Description
ME analysis population included randomized participants with cIAI who received study medication for >=48 h and clinical failure or clinical failure with treatment limiting AE and participants with >=72 h treatment and favorable microbiological response.
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description:
Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion.
Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
Overall Number of Participants Analyzed 40 15
Measure Type: Number
Unit of Measure: percentage of participants
0 0
Time Frame Baseline until the LFU visit (up to a maximum study duration of 50 days)
Adverse Event Reporting Description Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.
 
Arm/Group Title Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Hide Arm/Group Description Participants with Creatinine clearance(CrCL) >=50 milliliter per minute (mL/min) received 10 milligram per kilogram (mg/kg) intravenous(IV) infusion of metronidazole over 20 to 30 minutes along with 2 hour IV infusion of CAZ/AVI in following manner: 1)Age 6 to less than(<)18 years: 2000 mg CAZ/500 mg AVI (body weight >=40 kg), 50 mg/kg CAZ/12.5 mg/kg AVI (body weight <40 kg), 2) Age 6 months to <6 years: 50 mg/kg CAZ/12.5 mg/kg AVI, 3)Age 3 months to <6 months: 40 mg/kg CAZ/10 mg/kg AVI. Both infusions were administered to participants every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. Dose of CAZ-AVI was drops below to 50% if CrCl of participant drops below to 50mL/min, and participant was removed from study therapy, if CrCl decreased below 30mL/min. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at investigator's discretion. Participants received 15 to 30 minutes IV infusion of meropenem 20 mg/kg every 8 hours for a minimum of 72 hours and up to a maximum duration of 15 days. After having 72 hours of IV treatment, participants had option to switch to an oral therapy at the investigator's discretion.
All-Cause Mortality
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)   0/22 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Affected / at Risk (%) Affected / at Risk (%)
Total   5/61 (8.20%)   1/22 (4.55%) 
Gastrointestinal disorders     
Ileus * 1  1/61 (1.64%)  1/22 (4.55%) 
Intestinal obstruction * 1  1/61 (1.64%)  0/22 (0.00%) 
Large intestine perforation * 1  1/61 (1.64%)  0/22 (0.00%) 
Injury, poisoning and procedural complications     
Postoperative ileus * 1  1/61 (1.64%)  0/22 (0.00%) 
Renal and urinary disorders     
Renal colic * 1  1/61 (1.64%)  0/22 (0.00%) 
Urethral meatus stenosis * 1  1/61 (1.64%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ceftazidime- Avibactam (CAZ-AVI) Plus Metronidazole Meropenem
Affected / at Risk (%) Affected / at Risk (%)
Total   14/61 (22.95%)   6/22 (27.27%) 
Gastrointestinal disorders     
Abdominal pain * 1  0/61 (0.00%)  2/22 (9.09%) 
Vomiting * 1  9/61 (14.75%)  2/22 (9.09%) 
General disorders     
Infusion site phlebitis * 1  4/61 (6.56%)  0/22 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  1/61 (1.64%)  2/22 (9.09%) 
1
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02475733     History of Changes
Other Study ID Numbers: D4280C00015
C3591004 ( Other Identifier: Alias Study Number )
2014-003242-28 ( EudraCT Number )
First Submitted: May 25, 2015
First Posted: June 19, 2015
Results First Submitted: July 12, 2018
Results First Posted: August 9, 2018
Last Update Posted: August 9, 2018