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Also known as CXA-201
CXA-201 and metronidazole · 2 trials · 3 indications
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 | - |
| CXA-201 as treatment for cUTI | EXPERIMENTAL | CXA-201 IV infusion (1500mg q8) for 7 days |
| Levofloxacin as treatment for cUTI | ACTIVE_COMPARATOR | Levofloxacin IV infusion (750mg qd) for 7 days |
| 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 |
| CXA-201 | DRUG | CXA-201 IV infusion (1500mg q8) for 7 days |
| Levofloxacin | DRUG | Levofloxacin IV infusion (750mg qd) for 7 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 and metronidazole is being studied for the treatment of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis. It is an investigational antibiotic combination in Phase 3 development for these serious bacterial infections.
CXA-201 and metronidazole 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 this antibiotic combination.
CXA-201 and metronidazole is in Phase 3 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 3 program includes completed trials in complicated intra-abdominal infection and complicated urinary tract infection.
CXA-201 and metronidazole has been evaluated in two completed Phase 3 trials: NCT01445678, which compared it with meropenem in complicated intra-abdominal infections, and NCT01345929, which compared it with levofloxacin in complicated urinary tract infections including pyelonephritis. Both trials enrolled adults and have been completed.
The clinical program for CXA-201 and metronidazole enrolled a total of 558 patients across its trials. The complicated urinary tract infection trial NCT01345929 enrolled 558 patients, and the complicated intra-abdominal infection trial NCT01445678 enrolled 494 patients.