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NCT03358576 · ClinicalTrials.gov registry record · Phase 3
Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
A Phase 3 study, sponsored by Iterum Therapeutics, International Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 674
- Enrollment target
NCT03358576 is a Phase 3 study that has completed, run by Iterum Therapeutics, International Limited. The registered enrollment target is 674 participants.
The verdict
NCT03358576, a Phase 3 study, has completed, sponsored by Iterum Therapeutics, International Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 674 participants
- Enrollment target
Study 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.
Interventions
- DRUG Metronidazole
- DRUG Ciprofloxacin
- DRUG Ertapenem
- DRUG Sulopenem-Etzadroxil/Probenecid
- DRUG Amoxicillin-Clavulanate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 674 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2019-10-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03358576
The ClinicalTrials.gov registry entry for NCT03358576 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 674 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Iterum Therapeutics, International Limited, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Metronidazole is the first listed.
NCT03358576 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03358576 about?
NCT03358576 is a clinical study titled "Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)". 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.
What is the current status of trial NCT03358576?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 674 participants. The study started on 2018-09-18. Estimated completion is 2019-10-02.
What interventions are being tested in trial NCT03358576?
The interventions under investigation include: Metronidazole (DRUG), Ciprofloxacin (DRUG), Ertapenem (DRUG), Sulopenem-Etzadroxil/Probenecid (DRUG), Amoxicillin-Clavulanate (DRUG).
Who is sponsoring clinical trial NCT03358576?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
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