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A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia

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ClinicalTrials.gov Identifier: NCT01808092
Recruitment Status : Completed
First Posted : March 11, 2013
Results First Posted : February 3, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Nosocomial Pneumonia (NP)
Ventilator-associated Pneumonia (VAP)
Interventions: Drug: ceftazidim-avibactam (CAZ-AVI, experimental product)
Drug: meropenem (active comparator)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Overall, 879 patients were randomized in this study, from 4 geographic regions. The first patient was enrolled on 13 April 2013 and the last patient last visit was on 07 January 2016. Summary tables exclude 62 patients with moderate/severe renal impairment recruited prior to a protocol amendment to the dose regimen for such patients (MSRIBorig).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The first patient was enrolled on 13 April 2013 and the last patient last vist was on 07 January 2016. Overall, 969 patients were enrolled in this study, 90 of them screen failures.

Reporting Groups
  Description
CAZ-AVI 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
Meropenem meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo

Participant Flow:   Overall Study
    CAZ-AVI   Meropenem
STARTED   409   408 
COMPLETED   355   363 
NOT COMPLETED   54   45 
Death                39                29 
Lost to Follow-up                3                7 
Withdrawal by Subject                9                4 
Other Eligibility criteria                3                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline characteristics analysis is based on safety analysis set: randomized patients who received any amount of study therapy. 9 patients were randomized but not treated.

Reporting Groups
  Description
CAZ-AVI 2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
Meropenem meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
Total Total of all reporting groups

Baseline Measures
   CAZ-AVI   Meropenem   Total 
Overall Participants Analyzed 
[Units: Participants]
 405   403   808 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.8  (16.76)   61.7  (17.57)   61.7  (17.16) 
Age, Customized 
[Units: Participants]
     
18-45   74   74   148 
46-64   124   122   246 
65-74   97   95   192 
75-90   110   112   222 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      101  24.9%      105  26.1%      206  25.5% 
Male      304  75.1%      298  73.9%      602  74.5% 
Race/Ethnicity, Customized 
[Units: Participants]
     
Asian   226   217   443 
Black/African American   3   2   5 
Native Hawaiian/Pacific Islander   0   0   0 
Other   5   7   12 
White   171   177   348 


  Outcome Measures

1.  Primary:   The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set (Co-primary Analyses)   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

2.  Primary:   The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Clinically Evaluable at TOC Analysis Set (Co-primary Analyses)   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

3.  Secondary:   The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

4.  Secondary:   The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

5.  Secondary:   The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

6.  Secondary:   The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

7.  Secondary:   The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

8.  Secondary:   The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

9.  Secondary:   The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

10.  Secondary:   The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

11.  Secondary:   The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

12.  Secondary:   The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

13.  Secondary:   The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

14.  Secondary:   The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

15.  Secondary:   The Number of Patients With a Favorable Per-patient Microbiologic Response at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

16.  Secondary:   The Number of Patients With a Favorable Per-patient Microbiologic Response at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

17.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

18.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

19.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

20.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

21.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

22.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

23.  Secondary:   The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set at End of Treatment Visit   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

24.  Secondary:   The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Clinically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

25.  Secondary:   The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

26.  Secondary:   The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

27.  Secondary:   The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Clinically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

28.  Secondary:   The Number of Patients With Clinical Cure in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

29.  Secondary:   Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

30.  Secondary:   Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

31.  Secondary:   Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

32.  Secondary:   Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

33.  Secondary:   Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

34.  Secondary:   Number of Patients With a Favorable Per-patient Microbiologic Response in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

35.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set at End of Treatment Visit   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

36.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

37.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set   [ Time Frame: Patients were followed after the last IV dose but no later than 24 hours after the last IV dose. ]

38.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

39.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Extended Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

40.  Secondary:   The Number of Favorable Per-pathogen Microbiologic Responses in Patients With Pathogens Resistant to Ceftazidime at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

41.  Secondary:   The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set at Test-of-cure Visit   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

42.  Secondary:   The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in Clinically Modified Intent-to-treat Analysis Set at Test-of-cure Visit   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

43.  Secondary:   The Number of Patients With Death Due to Any Cause (All-cause Mortality) at Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set   [ Time Frame: At the test-of-cure (TOC) visit (Day 21 to 25) ]

44.  Secondary:   The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Microbiologically Modified Intent-to-treat Analysis Set at Day 28   [ Time Frame: at Day 28 from randomization ]

45.  Secondary:   The Number of Patients With Death Due to Any Cause (All-cause Mortality) in Clinically Modified Intent-to-treat Analysis Set at Day 28   [ Time Frame: at Day 28 from randomization ]

46.  Secondary:   The Number of Patients With Death Due to Any Cause (All-cause Mortality) in the Clinically Evaluable at Test-of-cure Analysis Set at Day 28   [ Time Frame: at Day 28 from randomization ]

47.  Secondary:   The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set   [ Time Frame: up to 25 days from randomization ]

48.  Secondary:   The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set   [ Time Frame: up to 25 days from randomization ]

49.  Secondary:   The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Evaluable at Test-of-cure Analysis Set   [ Time Frame: up to 25 days from randomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: David Wilson, Statistical Team Leader - Infection
Organization: AstraZeneca
phone: +44 1625 517830
e-mail: David.wilson2@astrazeneca.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01808092     History of Changes
Other Study ID Numbers: D4281C00001
First Submitted: February 28, 2013
First Posted: March 11, 2013
Results First Submitted: December 9, 2016
Results First Posted: February 3, 2017
Last Update Posted: September 6, 2017