Phase 3
N=817
A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia
Nosocomial Pneumonia (NP) · Ventilator-associated Pneumonia (VAP)
Bottom Line
View on ClinicalTrials.gov: NCT01808092 ↗Enrolled (actual)
817
Serious AEs
16.0%
Results posted
Feb 2017
Primary outcome: 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) — 245; 270; 79; 70 participants — p=0.007
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ceftazidim-avibactam (CAZ-AVI, experimental product) (Drug); meropenem (active comparator) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
245; 270; 79; 70; 32; 30 | 0.007 sig |
| 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) |
199; 211; 58; 59 | <0.001 sig |
| SECONDARY The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Modified Intent-to-treat Analysis Set |
120; 138; 37; 34; 14; 12 | — |
| SECONDARY The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Extended Microbiologically Evaluable Analysis Set |
96; 103; 29; 28 | — |
| SECONDARY The Number of Patients With Clinical Cure at Test-of-cure (TOC) Visit in the Microbiologically Evaluable Analysis Set |
85; 94; 22; 24 | — |
| SECONDARY The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Modified Intent-to-treat Analysis Set |
143; 161; 23; 18; 5; 5 | — |
| SECONDARY The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Modified Intent-to-treat Analysis Set |
292; 309; 50; 45; 14; 16 | — |
| SECONDARY The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Clinically Evaluable Analysis Set |
253; 268; 38; 38 | — |
| SECONDARY The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Extended Microbiologically Evaluable Analysis Set |
125; 135; 18; 16 | — |
| SECONDARY The Number of Patients With Clinical Cure at End of Treatment (EOT) Visit in Microbiologically Evaluable Analysis Set |
110; 126; 12; 12 | — |
| 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 |
128; 148; 38; 31; 5; 5 | — |
| 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 |
95; 118; 64; 54; 12; 12 | — |
| 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 |
112; 123; 31; 28 | — |
| 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 |
80; 89; 45; 42 | — |
| 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 |
96; 112; 26; 26 | — |
| 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 |
70; 83; 37; 35 | — |
| 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 |
6; 5; 25; 20; 15; 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 |
4; 5; 22; 17; 13; 17 | — |
| SECONDARY The Number of Favorable Per-pathogen Microbiologic Responses at End of Treatment (EOT) Visit in Microbiologically Evaluable at End of Treatment Analysis Set |
4; 5; 22; 17; 13; 17 | — |
| 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 |
5; 5; 21; 13; 13; 16 | — |
| 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 |
5; 3; 18; 7; 10; 16 | — |
| SECONDARY The Number of Favorable Per-pathogen Microbiologic Responses at Test-of-cure (TOC) Visit in Microbiologically Evaluable at Test-of-cure Analysis Set |
5; 3; 18; 7; 10; 16 | — |
| 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 |
40; 45; 32; 33; 3; 2 | — |
| 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 |
35; 42; 27; 31; 3; 2 | — |
| 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 |
31; 36; 27; 31; 3; 2 | — |
| 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 |
35; 40; 28; 29; 3; 2 | — |
| 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 |
29; 32; 23; 22; 5; 3 | — |
| 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 |
25; 26; 23; 22; 5; 3 | — |
| 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 |
35; 39; 10; 13; 1; 2 | — |
| 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 |
31; 36; 9; 13 | — |
| 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 |
26; 29; 7; 11 | — |
| 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 |
27; 27; 16; 23; 3; 4 | — |
| 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 |
23; 21; 14; 20 | — |
| 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 |
21; 18; 9; 14 | — |
| 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 |
3; 2; 6; 6; 5; 4 | — |
| 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 |
3; 2; 6; 5; 5; 4 | — |
| 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 |
3; 2; 6; 5; 5; 4 | — |
| 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 |
3; 2; 5; 5; 4; 4 | — |
| 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 |
4; 4; 4; 4; 11; 14 | — |
| 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 |
4; 4; 4; 4; 11; 13 | — |
| 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 |
16; 14; 6; 5; 10; 9 | — |
| 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 |
29; 25; 10; 6; 19; 19 | — |
| 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 |
11; 8; 5; 4; 6; 4 | — |
| 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 |
17; 16; 6; 5; 11; 11 | — |
| 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 |
30; 27; 10; 6; 20; 21 | — |
| 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 |
12; 9; 5; 4; 7; 5 | — |
| SECONDARY The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in Microbiologically Modified Intent-to-treat Analysis Set |
170; 182; 71; 75; 71; 74 | — |
| SECONDARY The Number of Patients Discharged From Hospital up to Test-of-cure (TOC) Visit in the Clinically Modified Intent-to-treat Analysis Set |
355; 366; 206; 206; 201; 200 | — |
| 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 |
256; 266; 148; 155; 144; 151 | — |
Summary
The purpose of the study is to evaluate the effects of Ceftazidime-Avibactam compared to Meropenem for treating hospitalized adults with nosocomial pneumonia including ventilator-associated pneumonia
Eligibility Criteria
Inclusion Criteria
- 18 to 90 years of age inclusive
- Females can participate if surgically sterile or completed menopause; if able to have children, must have negative serum pregnancy test, agree not to attempt pregnancy and use acceptable contraception while receiving study therapy and for 1 week after
- Onset of symptoms ≥ 48 hours after admission or 38 C) or hypothermia (rectal/core temperature 10,000 cells/mm3, or White blood cell count 15% band forms.
Exclusion Criteria
- Pulmonary disease that, in the investigator's judgment, would preclude evaluation of therapeutic response (e.g. lung cancer, active tuberculosis, cystic fibrosis, granulomatous disease, fungal pulmonary infection or recent pulmonary embolism).
- Patients with lung abscess, pleural empyema or post obstructive pneumonia.
- Patients with an estimated creatinine clearance <16ml/min by Cockcroft Gault formula or patients expected to require haemodialysis or other renal support while on study therapy.
- Acute hepatitis in the prior 6 months, cirrhosis, acute hepatic failure or acute decompensation of chronic hepatic failure.
- Patients receiving hemodialysis or peritoneal dialysis.
Data sourced from ClinicalTrials.gov (NCT01808092). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.