Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ceftazidim-avibactam · 1 trial · 2 indications
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
The number of patients meeting the cure criteria: the patient was not a clinical failure at end of treatment and the patient is alive and all signs and symptoms of pneumonia have resolved or improved to an extent that no antibacterial therapy for Nosocomial Pneumonia was taken between end of treatment and test-of-cure inclusive.
| Arm | Type | Description |
|---|---|---|
| CAZ-AVI | EXPERIMENTAL | Intra-Venous treatment |
| Meropenem | ACTIVE_COMPARATOR | Intra-Venous treatment |
| Name | Type | Description |
|---|---|---|
| ceftazidim-avibactam (CAZ-AVI, experimental product) | DRUG | 2000mg ceftazidime plus 500mg avibactam |
| meropenem (active comparator) | DRUG | 1000mg of Meropenem |
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 we...
Ceftazidim-avibactam is being studied for the treatment of nosocomial pneumonia, including ventilator-associated pneumonia, in hospitalized adults. It is an investigational small molecule antibacterial being developed by Pfizer for serious hospital-acquired infections within the infectious disease therapeutic area.
Ceftazidim-avibactam is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical program evaluating the agent in hospitalized adults with nosocomial pneumonia.
Ceftazidim-avibactam is in Phase 3 clinical development for nosocomial pneumonia. It is an investigational product and has not been approved for this indication. The Phase 3 program includes one completed trial with 969 enrolled patients.
Ceftazidim-avibactam has been evaluated in the Phase 3 trial NCT01808092, titled A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia. The trial is completed, enrolled 969 adults, and was conducted across sites in Europe, Asia, Latin America, and other regions.
Yes, ceftazidim-avibactam is also known as CAZ-AVI. It is an experimental product in Phase 3 development for nosocomial pneumonia, including ventilator-associated pneumonia, and is sponsored by Pfizer.
The Phase 3 trial NCT01808092 was a randomized, double-blind, active-controlled study comparing ceftazidim-avibactam with meropenem in hospitalized adults with nosocomial pneumonia, including ventilator-associated pneumonia. It enrolled 969 patients aged 18 years and older and has been completed.