Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAZ-AVI · 3 trials · 8 indications
The number 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 is necessary. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, death where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure. Results from two identical protocols D4280C00001 and D4280C00005 combined into a single database with agreement from FDA and EMA.
The number 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. Indeterminate response are where study data were not available for evaluation of efficacy for any reason, including patient lost to follow-up or assessment not undertaken such that a determination of clinical response could not be made, dDeath where cIAI was clearly noncontributory or circumstances that precluded classification as a cure or failure.
The number 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 number and types of microorganisms in faeces.
Key PK parameters were prespecified to be calculated for cohorts 1 and 2. For cohorts 3 and 4 (where children were \<6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.
Key PK parameters are shown for cohorts 1 and 2. For cohorts 3 and 4 (where children were \<6 years of age), sparse sampling scheme was used for PK samples to limit the volume of blood required. PK parameters cannot be derived from these sparse PK samples without population PK analysis. Thus the PK is not described here, but will be reported in a separate population PK report.
| Arm | Type | Description |
|---|---|---|
| CAZ-AVI + Metronidazole | EXPERIMENTAL | IV treatment |
| Meropenem | ACTIVE_COMPARATOR | IV treatment |
| CAZ-AVI or CXL | EXPERIMENTAL | Cohort 1: CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) by intravenous infusion given over 2 hours, every 8 hours Cohort 2: CXL (600 mg ceftaroline fosamil and 600 mg avibactam) |
| CAZ-AVI | EXPERIMENTAL | This arm will include 4 cohorts. Patients will be stratified by age. |
| Name | Type | Description |
|---|---|---|
| CAZ-AVI | DRUG | Ceftazidime 2000 mg and 500 mg of avibactam |
| Metronidazole | DRUG | 500 mg of Metronidazole |
| Meropenem | DRUG | 1 gram of Meropenem |
| CXL | DRUG | IV infusion |
Inclusion Criteria: * 18 to 90 years of age inclusive * Female patient is authorized to participate if at least one of the following criteria are met: 1. Surgical sterilization 2. Age ≥50 years and postmenopausal as defined by amenorrhea for 12 months or more following cessation of all exogeno...
CAZ-AVI is being studied for the treatment of complicated intra-abdominal infections and systemic infections. It is an investigational combination antibiotic developed by Pfizer, Inc. for infectious disease indications. Clinical development has included pediatric and adult patient populations as well as healthy volunteer studies.
CAZ-AVI is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating the combination in complicated intra-abdominal infections and systemic infections.
CAZ-AVI has been evaluated across Phase 1 and Phase 3 clinical trials. The Phase 3 study in complicated intra-abdominal infections has completed, and Phase 1 studies in pediatric patients and healthy volunteers have also completed. CAZ-AVI is an investigational agent and is not described as approved.
CAZ-AVI has been studied in completed trials including NCT01499290, a Phase 3 comparison with meropenem plus metronidazole in hospitalized adults with complicated intra-abdominal infections, NCT01893346, a Phase 1 pediatric safety and tolerability study, and NCT01789528, a Phase 1 study of effects on intestinal flora in healthy volunteers.
The largest CAZ-AVI trial, NCT01499290, enrolled 493 hospitalized adults with complicated intra-abdominal infections across 20 countries. The Phase 1 pediatric study NCT01893346 enrolled 35 patients, and the healthy volunteer study NCT01789528 enrolled 48 participants.
Yes, CAZ-AVI is an abbreviation for ceftazidime-avibactam, a small molecule combination antibiotic. The two names refer to the same investigational agent developed by Pfizer, Inc. for complicated intra-abdominal infections and systemic infections.