Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ceftazidim-avibactam (CAZ-AVI, experimental product)
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...