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Also known as CXA-101
CXA-101/tazobactam · 2 trials · 2 indications
Clinical response is complete resolution or significant improvement of all signs and symptoms of the index infection, such that no additional antibacterial therapy or surgical or drainage procedure was required for the index infection.
Microbiological response is eradication for each baseline pathogen
Microbiological response is eradication for each baseline pathogen
| Arm | Type | Description |
|---|---|---|
| CXA 101/tazobactam and metronidazole | EXPERIMENTAL | - |
| meropenem with matching saline placebo | ACTIVE_COMPARATOR | - |
| 1 | EXPERIMENTAL | CXA-101 |
| 2 | ACTIVE_COMPARATOR | Ceftazidime |
| Name | Type | Description |
|---|---|---|
| CXA-101/ tazobactam and metronidazole | DRUG | CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion |
| meropenem plus saline placebo | DRUG | meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion |
| CXA-101 | DRUG | intravenous |
| Ceftazidime | DRUG | intravenous |
Inclusion Criteria: * Male or female, from 18 to 90 years of age, inclusive * One of the following diagnoses (in which there is evidence of intraperitoneal infection) including:(a) Cholecystitis (including gangrenous cholecystitis) with rupture, perforation, or progression of the infection beyond t...
CXA-101/tazobactam is an investigational small molecule antibiotic combination being developed for serious bacterial infections. It pairs CXA-101 with tazobactam, a beta-lactamase inhibitor. It has been studied in Phase 2 clinical trials for complicated intra-abdominal infection and complicated urinary tract infection, and it is not yet approved.
CXA-101/tazobactam has been studied for the treatment of complicated intra-abdominal infection and complicated urinary tract infection in hospitalized adults. Both are serious bacterial infections. The clinical program remains investigational, so the combination does not currently have an approved indication.
CXA-101/tazobactam is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. Merck is the sponsor of the clinical program evaluating the combination in complicated intra-abdominal infection and complicated urinary tract infection.
CXA-101/tazobactam is in Phase 2 development. Two completed Phase 2 trials have evaluated the combination, one in complicated intra-abdominal infection and one in complicated urinary tract infection. It is an investigational agent and has not been approved by the FDA for any indication.
CXA-101/tazobactam has been evaluated in two completed Phase 2 trials. NCT01147640 compared intravenous CXA-101/tazobactam plus metronidazole with meropenem in complicated intra-abdominal infections across the United States, Argentina, Georgia, Russia and Serbia. NCT00921024 studied intravenous CXA-101 against ceftazidime in complicated urinary tract infections in the United States, Germany and Poland.
CXA-101 is the beta-lactam component of the CXA-101/tazobactam combination, so the names refer to related but not identical things. CXA-101/tazobactam has also been studied with metronidazole added, as in the complicated intra-abdominal infection trial. Searches for CXA-101 generally refer to this same development program.