Phase 3
N=333
Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens
Complicated Urinary Tract Infection · Complicated Intra-abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT01644643 ↗Enrolled (actual)
333
Serious AEs
5.7%
Results posted
Dec 2015
Primary outcome: Primary: Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set — 6; 8; 129; 132 Participant
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ceftazidime - Avibactam ( CAZ-AVI) (Drug); Best Available Therapy (Drug); Metronidazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at Test of Cure (TOC) in Microbiological Modified Intent-to-treat (mMITT) Analysis Set |
6; 8; 129; 132; 0; 0 | — |
| SECONDARY Clinical Response at End of Treatment (EOT) in mMITT Analysis Set. |
6; 9; 136; 142; 0; 0 | — |
| SECONDARY Clinical Response at Follow-up 1 (FU1) in mMITT Analysis Set |
6; 8; 121; 127; 0; 0 | — |
| SECONDARY Clinical Response at Follow-up 2 (FU2) in mMITT Analysis Set |
118; 123; 13; 11; 6; 10 | — |
| SECONDARY Clinical Response at EOT in Extended Microbiologically Evaluable (EME) at EOT Analysis Set. |
5; 9; 127; 134; 0; 0 | — |
| SECONDARY Clinical Response at TOC in EME at TOC Analysis Set. |
5; 8; 120; 126; 0; 0 | — |
| SECONDARY Clinical Response at FU1 in EME at FU1 Analysis Set. |
5; 7; 110; 120; 0; 0 | — |
| SECONDARY Clinical Response at FU2 in EME at FU2 Analysis Set |
102; 106; 12; 10 | — |
| SECONDARY Clinical Cure at TOC by Baseline Gram-negative Pathogen in mMITT Analysis Set |
2; 3; 54; 53; 2; 3 | — |
| SECONDARY Clinical Cure at TOC by Baseline Gram-negative Pathogen in EME at TOC Analysis Set |
2; 3; 47; 51; 2; 3 | — |
| SECONDARY Clinical Cure at TOC by Previously Failed Treatment Class in mMITT Analysis Set |
3; 7; 12; 6; 0; 1 | — |
| SECONDARY Clinical Cure at EOT by Previously Failed Treatment Class in EME at EOT Analysis Set |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Clinical Cure at TOC by Previously Failed Treatment Class in EME at TOC Analysis Set |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Clinical Cure at FU1 by Previously Failed Treatment Class in EME at FU1 Analysis Set |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Clinical Cure at FU2 by Previously Failed Treatment Class in EME at FU2 Analysis Set |
0; 0; 0; 0; 0; 2 | — |
| SECONDARY Per-patient Microbiological Response at EOT in mMITT Analysis Set |
6; 9; 130; 136; 0; 0 | — |
| SECONDARY Per-patient Microbiological Response at TOC in mMITT Analysis Set |
6; 8; 88; 118; 0; 0 | — |
| SECONDARY Per-patient Microbiological Response at FU1 in mMITT Analysis Set |
6; 8; 78; 103; 0; 0 | — |
| SECONDARY Per-patient Microbiological Response at FU2 in mMITT Analysis Set |
73; 99; 54; 35; 10; 10 | — |
| SECONDARY Per-patient Microbiological Response at EOT in EME at EOT Analysis Set |
5; 9; 127; 133; 0; 0 | — |
| SECONDARY Per-patient Microbiological Response at TOC in EME at TOC Analysis Set |
5; 8; 84; 114; 0; 0 | — |
| SECONDARY Per-patient Microbiological Response at FU1 in EME at FU1 Analysis Set |
5; 7; 75; 98; 0; 0 | — |
| SECONDARY Per-patient Microbiological Response at FU2 in EME at FU2 Analysis Set |
68; 85; 47; 32 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in mMITT Analysis Set |
2; 3; 53; 57; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in mMITT Analysis Set |
2; 3; 38; 52; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in mMITT Analysis Set |
2; 3; 33; 45; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in mMITT Analysis Set |
32; 43; 19; 14; 6; 2 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at EOT in EME at EOT Analysis Set |
2; 3; 51; 55; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC in EME at TOC Analysis Set |
2; 3; 34; 50; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at FU1 in EME at FU1 Analysis Set |
2; 3; 30; 43; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at FU2 in EME at FU2 Analysis Set |
28; 39; 16; 11; 33; 32 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in mMITT Analysis Set |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Per-pathogen Microbiological Response of Gram-negative Pathogen at TOC by CAZ-AVI MIC in EME at TOC Analysis Set |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY The Reason for Treatment Change/Discontinuation in mMITT Analysis Set |
1; 0; 8; 11; 1; 0 | — |
| SECONDARY The 28 Days All Cause Mortality Rate in mMITT Analysis Set |
1; 0; 3; 3; 0; 0 | — |
| SECONDARY The 28 Days All Cause Mortality Rate in EME at TOC Analysis Set |
0; 0; 1; 1; 0; 0 | — |
| SECONDARY Plasma Concentrations for Ceftazidime and Avibactam - cIAI in PK Analysis Set |
23880.3; 3061.3; 39465.3; 6304.1; 14904.8; 1769.3 | — |
| SECONDARY Plasma Concentrations for Ceftazidime and Avibactam - cUTI in PK Analysis Set |
74260.2; 10103.8; 56905.9; 8141.2; 21442.0; 2425.0 | — |
Summary
To Evaluate the Effects of Ceftazidime-Avibactam and Best Available Therapy in patients with complicated urinary tract infections and complicated intra-abdominal infections.
Eligibility Criteria
Inclusion Criteria
- Patient must be ≥18 and ≤90 years of age
- Female patients can participate if they are surgically sterile or completed menopause or females capable of having children and agree not to attempt pregnancy while receiving IV study therapy and for a period of 7 days after
- Patient has a ceftazidime-resistant Gram negative pathogen that was isolated from an appropriate culture within 5 days prior to study entry (ie, within 5 days prior to Screening; the study-qualifying culture), which was determined to be the causative agent of the entry infection
Exclusion Criteria
- Patient has an APACHE II score >30 (cIAI patients only)
- Patient has an infection due to Gram negative pathogen that is unlikely to respond to CAZ-AVI treatment (eg, Acinetobacter spp., Stenotrophomonas spp.)
- Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant Patient is immunocompromised
- Patient has a rapidly progressive or terminal illness with a high risk of mortality due to any cause, including acute hepatic failure, respiratory failure or severe septic shock such that they are unlikely to survive the 4- to 5-week study period.
Data sourced from ClinicalTrials.gov (NCT01644643). 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.