Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CAZ-AVI · 5 trials · 10 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.
AE: The onset of an AE relative to treatment will be calculated as the time difference between the onset (date and time) of the AE and the start time of the last dose (date and time) prior to the AE; the duration of a resolved AE will be calculated as the difference between the resolution (date and time) of the AE and the onset (date and time) of the AE. Vital signs and oral temperature:Change in BP, pulse rate and oral temperature at each post treatment time point will be calculated as the post treatment measurement value minus the baseline value observed on Day -1. Physical examination: complete physical examination and brief physical examination. ECG: heart rate, RR, PR, QRS, and QT intervals from the 12-lead ECG and the derived variable QTcF. Safety laboratory (hematology, chemistry and urinalysis): Change in laboratory test value at each post treatment time point will be calculated as the post treatment value minus the baseline value observed on Day -1 .
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 |
| Placebo | PLACEBO_COMPARATOR | IV infusions of 0.9% normal saline |
| CAZ-AVI | EXPERIMENTAL | IV infusion of AVI 500 mg + CAZ 2000 mg. |
| 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) |
| CAZAVI | EXPERIMENTAL | CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) |
| Metronidazole | ACTIVE_COMPARATOR | Metronidazole (500 mg) |
| CAZAVI+metronidazole | ACTIVE_COMPARATOR | CAZ-AVI (2000mg ceftazidime/500 mg avibactam) + metronidazole (500 mg) |
| 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 |
| 0.9% Normal Saline | DRUG | A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9. |
| CXL | DRUG | IV infusion |
| CAZ-AVI + metronidazole | DRUG | 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, also known as ceftazidime-avibactam, is an investigational small molecule being studied for complicated intra-abdominal infections, systemic infections, and pharmacokinetic effects in healthy volunteers. It is a combination antibiotic being developed by Pfizer, Inc. for the treatment of serious bacterial infections.
CAZ-AVI is a combination of ceftazidime, a cephalosporin antibiotic, and avibactam, a beta-lactamase inhibitor. It works by inhibiting bacterial cell wall synthesis and protecting ceftazidime from degradation by beta-lactamase enzymes, thereby restoring its activity against resistant bacteria.
CAZ-AVI is being developed by Pfizer, Inc., a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of this combination antibiotic for various infectious disease indications.
CAZ-AVI has completed Phase 3 clinical trials for complicated intra-abdominal infections. It has also completed Phase 1 trials for healthy volunteers, pharmacokinetics, and systemic infections. The drug is investigational and still in clinical development, with no approval status indicated.
CAZ-AVI has completed four clinical trials. NCT01499290 was a Phase 3 study comparing ceftazidime-avibactam plus metronidazole versus meropenem in 493 adults with complicated intra-abdominal infections. NCT01534247 and NCT01789528 were Phase 1 pharmacokinetic studies in healthy volunteers. NCT01893346 was a Phase 1 safety study in pediatric patients with systemic infections.
Yes, CAZ-AVI is the same as ceftazidime-avibactam. The drug is a fixed-dose combination of ceftazidime and avibactam, and it is referred to by the abbreviation CAZ-AVI in clinical trial documentation and research literature.