Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CXA-201 and metronidazole · 1 trial · 1 indication
Clinical cure is complete resolution or significant improvement in 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-201 and Metronidazole as treatment for cIAI | EXPERIMENTAL | - |
| Meropenem as treatment for cIAI | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| CXA-201 and metronidazole | DRUG | CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days |
| Meropenem | DRUG | Meropenem IV infusion (1000mg q8h) for 4-14 days |
Inclusion Criteria: * Diagnoses of cIAI. * Subject requires surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of (before or after) the first dose of study drug. Exclusion Criteria: * Simple appendicitis; acute suppurative cholan...
CXA-201 is an investigational small molecule being developed for complicated urinary tract infection and complicated intra-abdominal infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
CXA-201 is a small molecule antibiotic, though its specific molecular target has not been disclosed. It is being studied for its efficacy against bacterial infections in complicated urinary tract and intra-abdominal settings.
CXA-201 is being developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker MRK. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy.
CXA-201 is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Two Phase 3 trials have been completed, with a total enrollment of over 1,000 patients.
CXA-201 has completed two Phase 3 trials. NCT01345929 compared intravenous CXA-201 to levofloxacin in complicated urinary tract infection, enrolling 558 patients. NCT01445678 compared it to meropenem in complicated intra-abdominal infection, enrolling 494 patients. Both were randomized, double-blind, active-controlled studies.
CXA-201 is not the same as ceftolozane/tazobactam. CXA-201 is a distinct investigational antibiotic being developed by Merck. No alternative names for CXA-201 have been disclosed in the clinical trial data.