Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)
Public ClinicalTrials.gov record NCT03358576. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of Efiicacy, Tolerability & Safety of Sulopenem & Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro-metronidazole for Treatment of cIAI in Adults
Study identification
- NCT ID
- NCT03358576
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Iterum Therapeutics, International Limited
- Industry
- Enrollment
- 674 participants
Conditions and interventions
Conditions
Interventions
- Amoxicillin-Clavulanate Drug
- Ciprofloxacin Drug
- Ertapenem Drug
- Metronidazole Drug
- Sulopenem Drug
- Sulopenem-Etzadroxil/Probenecid Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 17, 2018
- Primary completion
- Oct 1, 2019
- Completion
- Oct 1, 2019
- Last update posted
- Nov 30, 2020
2018 – 2019
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Medical Facility | Chula Vista | California | 91911 | — |
| Medical Facility | Torrance | California | 90509 | — |
| Medical Facility | Idaho Falls | Idaho | 83404 | — |
| Medical Facility | Boston | Massachusetts | 02111 | — |
| Medical Facility | Royal Oak | Michigan | 48073 | — |
| Medical Facility | St Louis | Missouri | 63110 | — |
| Medical Facility | Butte | Montana | 59701 | — |
| Medical Facility | Lincoln | Nebraska | 68510 | — |
| Medical Facility | Omaha | Nebraska | 68114 | — |
| Medical Facility | Somers Point | New Jersey | 08244 | — |
| Medical Facility | Columbus | Ohio | 43210 | — |
| Medical Facility | Columbus | Ohio | 43215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 30 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03358576, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 30, 2020 · Synced May 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03358576 live on ClinicalTrials.gov.