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ceftazidime/NXL104+ metronidazole · 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/NXL104+ metronidazole is an investigational combination being studied for the treatment of complicated intra-abdominal infections. It combines the antibiotic ceftazidime with NXL104, a beta-lactamase inhibitor, plus metronidazole. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Ceftazidime/NXL104+ metronidazole is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. The company is conducting clinical trials to evaluate this combination therapy for complicated intra-abdominal infections.
Ceftazidime/NXL104+ metronidazole is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The Phase 2 trial has been completed, and the drug remains under evaluation for the treatment of complicated intra-abdominal infections.
Ceftazidime/NXL104+ metronidazole has one completed Phase 2 trial registered as NCT00752219. This was a prospective, multicenter, double-blind, randomized study comparing NXL104/ceftazidime plus metronidazole versus meropenem in patients with complicated intra-abdominal infections. The trial enrolled 204 participants across multiple countries.
Ceftazidime/NXL104+ metronidazole combines ceftazidime, a cephalosporin antibiotic, with NXL104, a beta-lactamase inhibitor, and metronidazole, an antibiotic effective against anaerobic bacteria. The NXL104 component is designed to protect ceftazidime from degradation by beta-lactamase enzymes, potentially broadening its activity against resistant bacteria.
Ceftazidime/NXL104+ metronidazole is a specific combination product being developed by Pfizer. It is not known by other names in the available information. The combination includes ceftazidime, NXL104, and metronidazole, each of which may be available separately, but this particular fixed combination is unique to the investigational program.