drugset / Trial / NCT03358576
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.
Timeline
- Start
- 2018-09-18
- Primary completion
- 2019-10-02
- Completion
- 2019-10-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ertapenem | Small molecule | 1000 mg | Intravenous |
| Subject | Sulopenem | Small molecule | 1000 mg | Intravenous |
| Subject | sulopenem etzadroxil | Small molecule | 500 mg | Oral |
| Comparator | Amoxicillin | Other / unclassified | 875 mg | Oral |
| Comparator | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Comparator | Metronidazole | Small molecule | 500 mg | Oral |
| Background | Probenecid | Small molecule | — | Oral |