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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: Completed Phase 3 study, sponsored by Iterum Therapeutics, International Limited.
NCT03358576 is a Phase 3 study that has completed, run by Iterum Therapeutics, International Limited. The registered enrollment target is 674 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions
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 |
What the finished NCT03358576 record still lists
NCT03358576 is an interventional study that assigns participants to a tested intervention. The registered 674 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 5 interventions - of which Metronidazole is the first listed.
NCT03358576 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03358576's enrollment target sits among peer trials
674 543rd of 2000 higher than 1,457 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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