Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections (RECLAIM3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01726023
First received: November 5, 2012
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
The purpose of this study is to evaluate the effects of Ceftazidime Avibactam plus Metronidazole compared to Meropenem for treating hospitalized patients with complicated intra-abdominal infections.

Condition Intervention Phase
Complicated Intra-abdominal Infection
Drug: Ceftazidime-avibactam
Drug: metronidazole
Drug: Meropenem
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Clinically Evaluable (CE) Analysis Set. [ Time Frame: At the test of cure visit (Day 28 to35) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.


Secondary Outcome Measures:
  • The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the End of Treatment (EOT) Visit in the Clinically Evaluable (CE) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With Clinical Cure at the Late Follow up (LFU) Visit in the Clinically Evaluable (CE) Analysis Set. [ Time Frame: At late follow up (LFU) visits (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients meeting the cure criteria: complete resolution or significant improvement of signs and symptoms of the index infection such that no further antibacterial therapy, drainage, or surgical intervention was necessary.

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Patients With a Favorable Per-patient Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    Per-patient "favorable" response indicates that all of the patient's baseline pathogens are "eradicated" or "presumed eradicated".

  • The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Test of Cure (TOC) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response in the Microbiological Response at the Late Follow up (LFU) Visit in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response at the End of Treatment (EOT) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the end of treatment (EOT) (within 24 hours after last IV dose) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response at the Test of Cure (TOC) Visit in the Extended Microbiologically Evaluable(ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Favorable Per-pathogen Microbiological Response at the Late Follow up (LFU) Visit in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the late follow up (LFU) (Day 42 to 49) ] [ Designated as safety issue: No ]
    The proportion of patients with a favorable per-pathogen microbiological response: favourable microbiological response includes: Eradication Absence of causative pathogen from specimens at the site of infection. Presumed eradication where, repeat cultures were not performed/clinically indicated in a patient who had a clinical response of cure.

  • The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).

  • The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).

  • The Proportion of Patients With a Favorable Per Patient Microbiological Response at the Test of Cure (TOC) Visit for Patients Infected With Ceftazidime Resistant Pathogens in the Extended Microbiologically Evaluable (ME) Analysis Set. [ Time Frame: At the test of cure (TOC) (Day 28 to 35) ] [ Designated as safety issue: No ]
    The microbiological responses as per the protocoled criteria: responses other than "indeterminate" were classified as "favorable" or "unfavorable." Favorable microbiological response assessments included "eradication" and "presumed eradication." Unfavorable microbiological response assessments included "persistence," "persistence with increasing minimum inhibitory concentration (MIC)," and "presumed persistence." Indeterminate microbiologic response assessments included cases where the clinical response was changed to indeterminate due to an SRP assessment of inadequate source control (ie, circumstances that preclude classification as eradication, presumed eradication, persistence, persistence with increasing MIC, and presumed persistence).

  • The Time to First Defervescence in the Clinically Evaluable (CE) Analysis Set for Patients Who Have Fever at Study Entry. [ Time Frame: while on study therapy (from Day 1 to Day 14) ] [ Designated as safety issue: No ]
    Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.

  • The Time to First Defervescence in the Microbiological Modified Intent-to-treat (mMITT) Analysis Set for Patients Who Have Fever at Study Entry. [ Time Frame: while on study therapy (from Day 1 to Day 14) ] [ Designated as safety issue: No ]
    Time to first defervescence was calculated for patients with a fever (>38ºC) at baseline. Defervescence (≤37.8ºC) was defined as the absence of fever based on the highest temperature recorded on each study day. Time to first defervescence while on IV study therapy in the CE analysis set at TOC for patients who had fever at study entry is defined as time (in days) from the first dose of IV study therapy to first absence of fever.

  • Safety and Tolerability by Incidence and Severity of Adverse Events and Serious Adverse Events and Mortality. [ Time Frame: study duration (from screening to Day 49 LFU visit) ] [ Designated as safety issue: No ]
    Adverse event data were collected from the screening/consent visit until the late follow-up visit (i.e. Day -1/0 to Day 42).

  • Safety and Tolerability by Incidence: Extent of Exposure. [ Time Frame: study duration (from screening to Day 49 LFU visit) ] [ Designated as safety issue: No ]
    Duration of exposure is calculated as the difference between the last study therapy date and the first study therapy date converted to days plus 1 day. Actual calculated duration could be shorter or longer than a full day.

  • Safety and Tolerability: Clinical Laboratory Evaluation Hematology. [ Time Frame: study duration (from screening to Day 49 LFU visit) ] [ Designated as safety issue: No ]
    Potentially clinically significant (PCS) post Baseline hematology values up to LFU (Safety analysis set)

  • Safety and Tolerability: Clinical Laboratory Evaluation Clinical Chemistry. [ Time Frame: study duration (from screening to Day 49 LFU visit) ] [ Designated as safety issue: No ]
    Potentially clinically significant (PCS) post Baseline clinical chemistry values up to LFU (Safety analysis set)

  • Safety and Tolerability:ECG , QTcB and QTcF Intervals [ Time Frame: EOT visit/any observation on treatment ] [ Designated as safety issue: No ]
    Shifts in ECG interpretation and changes in QT, QTcB, and QTcF intervals , from baseline to post baseline.

  • Plasma Concentrations for Ceftazidime and Avibactam [ Time Frame: At Day 3: Anytime within 15 minutes prior to or after stopping study drug, anytime between 30 and 90 minutes after stopping study drug, anytime between 300 minutes and 360 minutes after stopping study drug. ] [ Designated as safety issue: No ]
    Blood samples were taken from all patients on Day 3 for the pharmacokinetic evaluation of ceftazidime and avibactam plasma concentrations


Enrollment: 486
Study Start Date: January 2013
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ceftazidime-Avibactam plus metronidazole Drug: Ceftazidime-avibactam
Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
Drug: metronidazole
Metronidazole 500mg/100ml solution for infusion
Active Comparator: Meropenem Drug: Meropenem
Meropenem powder for solution for infusion 1000mg

Detailed Description:
A Phase III, Randomized, Multicenter, Double Blind, Double-Dummy, Parallel-Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam Plus Metronidazole Versus Meropenem in the Treatment of Complicated Intra-Abdominal Infections In Hospitalized Adults
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must be 18 to 90 years of age, inclusive,
  • Female patients can participate if they are surgically sterilized or postmenopausal for at least 1 year or her sexual partner has had a vasectomy
  • Female of childbearing potential has had normal menstrual periods for 3 months and negative serum pregnancy test and agree to practice highly effective methods of birth control during treatment and for at least 7 days after last dose
  • Intraoperative/postoperative enrollment with visual confirmation (presence of pus within the abdominal cavity) of an intra-abdominal infection associated with peritonitis
  • Confirmation of infection by surgical intervention within 24 hours of entry: evidence of systemic inflammatory indicators; physical findings consistent with intra-abdominal infection; supportive radiologic imaging findings of intra-abdominal infections

Exclusion Criteria:

  • Patient is diagnosed with traumatic bowel perforation undergoing surgery within 12 hours; perforation of gastroduodenal ulcers undergoing surgery within 24 hours. Other intra-abdominal processes in which primary etiology is not likely to be infectious
  • Patient has abdominal wall abscess or bowel obstruction without perforation or ischemic bowel without perforation
  • Patients whose surgery will include staged abdominal repair, or "open abdomen" technique, or marsupialization
  • Patient has suspected intra-abdominal infections due to fungus, parasites, virus or tuberculosis
  • Patient is considered unlikely to survive the 6- to 8-week study period or has a rapidly progressive or terminal illness, including septic shock that is associated with a high risk of mortality
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01726023

Locations
China
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Chengdu, China
Research Site
Chongqing, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Guilin, China
Research Site
Haikou, China
Research Site
Hebei, China
Research Site
Jiangyin, China
Research Site
Liaocheng, China
Research Site
Nan Chang, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Research Site
Urumqi, China
Research Site
Wenzhou, China
Research Site
Wuxi, China
Research Site
Xi'an, China
Korea, Republic of
Research Site
Ansan-si, Korea, Republic of
Research Site
Anyang-si, Korea, Republic of
Research Site
Busan, Korea, Republic of
Research Site
Cheongju-si, Korea, Republic of
Research Site
Daejeon, Korea, Republic of
Research Site
Gwangju, Korea, Republic of
Research Site
Jinju-si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Wonju-si, Korea, Republic of
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Hochiminh, Vietnam
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paul A Newell, MBBS, MRCP AstraZeneca
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01726023     History of Changes
Other Study ID Numbers: D4280C00018  2011-003893-97 
Study First Received: November 5, 2012
Results First Received: February 1, 2016
Last Updated: March 16, 2016
Health Authority: China: Food and Drug Administration
Korea: Food and Drug Administration
Vietnam: Ministry of Health

Keywords provided by AstraZeneca:
Ceftazidime-avibactam,
Metronidazole,
Meropenem,
Anti-Bacterial Agents,
Anti-Infective Agents,
Therapeutic Uses,
Pharmacologic Actions,
Physiological Effects of Drugs

Additional relevant MeSH terms:
Infection
Intraabdominal Infections
Ceftazidime
Meropenem
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 04, 2016