Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ceftazidime · 1 trial · 1 indication
Clinical response was defined as complete resolution or significant improvement of signs and symptoms of the index infection. No further antimicrobial therapy or surgical or radiological intervention was required. This clinical response was measured in participants who were microbiologically evaluable (ME) at baseline.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 6 weeks after last dose of study treatment that were absent before treatment or that worsened relative to pretreatment state.
| Arm | Type | Description |
|---|---|---|
| NXL104/CAZ/MTZ | EXPERIMENTAL | NXL104/ceftazidime + metronidazole |
| Meropenem | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ceftazidime/NXL104 + metronidazole | DRUG | IV TID |
| meropenem | DRUG | IV TID |
Inclusion Criteria: * complicated intra-abdominal infections Exclusion Criteria: * infections limited to hollow viscus * ischemic bowel disease without perforation * acute suppurative cholangitis * acute necrotizing pancreatitis * pts to undergo stated abdominal repair, open abdomen technique or ...
Ceftazidime is being studied in a combination regimen for the treatment of complicated intra-abdominal infections. In this program it is given with NXL104 and metronidazole and was compared against meropenem in a Phase 2 trial in adults 18 years and older. It is an investigational use, not an approved indication.
Pfizer, Inc. is the developer of the ceftazidime combination program for complicated intra-abdominal infections. Pfizer trades on the New York Stock Exchange under the ticker PFE. The company sponsored the Phase 2 study evaluating ceftazidime with NXL104 and metronidazole in this indication.
Ceftazidime in combination with NXL104 and metronidazole is in Phase 2 development for complicated intra-abdominal infections. The program has one completed Phase 2 trial and no active trials. It is an investigational regimen and is not approved for this indication.
The trial is NCT00752219, titled a prospective multicenter double-blind randomized study of NXL104/ceftazidime plus metronidazole versus meropenem in the treatment of complicated intra-abdominal infections. It was a completed Phase 2 study that enrolled 204 participants across the United States, Bulgaria, France, India, Lebanon, Poland, Romania, and Russia.
NCT00752219 was a randomized, double-blind, active-controlled Phase 2 trial. Participants 18 years and older with complicated intra-abdominal infections were assigned to NXL104/ceftazidime plus metronidazole or to meropenem. The study enrolled 204 participants, was conducted in eight countries, and is completed. Healthy volunteers were not included.