Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CXA-101/ tazobactam and metronidazole · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| CXA 101/tazobactam and metronidazole | EXPERIMENTAL | - |
| meropenem with matching saline placebo | ACTIVE_COMPARATOR | - |
| 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 |
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 is an investigational small molecule being studied for complicated urinary tract infections, complicated intra-abdominal infections, and in healthy subjects for safety evaluations. It is in Phase 2 clinical development for the infectious disease therapeutic area.
CXA-101 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in infectious disease indications.
CXA-101 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and effectiveness.
CXA-101 has completed three clinical trials. NCT00921024 studied it in complicated urinary tract infections with 129 participants. NCT01147640 evaluated it in complicated intra-abdominal infections with 122 participants. NCT02508753 assessed its effects on QT/QTc intervals in 52 healthy subjects.
CXA-101 is the base drug, and CXA-101/Tazobactam is a combination formulation that includes tazobactam. Clinical trials have evaluated both the single agent and the combination, with the combination studied in intra-abdominal infections and healthy subjects.