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Completed Phase 3 Interventional Results available

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

ClinicalTrials.gov ID: NCT03357614

Public ClinicalTrials.gov record NCT03357614. 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.

ClinicalTrials.gov public records Last synced Jul 23, 2026, 12:09 PM EDT

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, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults

Study identification

NCT ID
NCT03357614
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Iterum Therapeutics, International Limited
Industry
Enrollment
1,395 participants

Conditions and interventions

Interventions

  • Sulopenem Drug
  • Sulopenem-Etzadroxil/Probenecid Drug
  • Ertapenem Drug
  • Ciprofloxacin Drug
  • Amoxicillin-clavulanate 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
Dec 13, 2019
Completion
Dec 13, 2019
Last update posted
Dec 28, 2020

2018 – 2019

United States locations

U.S. sites
15
U.S. states
9
U.S. cities
14
Facility City State ZIP Site status
Medical Facility Bellflower California 90706
Medical Facility Chula Vista California 91911
Medical Facility La Mesa California 91942
Medical Facility La Palma California 90623
Medical Facility Torrance California 90502
Medical Facility Miami Lakes Florida 33014
Medical Facility Columbus Georgia 31904
Medical Facility Idaho Falls Idaho 83404
Medical Facility Boston Massachusetts 02111
Medical Facility Royal Oak Michigan 48073
Medical Facility Butte Montana 59701
Medical Facility Columbus Ohio 43214
Medical Facility Columbus Ohio 43215
Medical Facility Dallas Texas 75246
Medical Facility Houston Texas 77057

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 17 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03357614, 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 Dec 28, 2020 · Synced Jul 23, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03357614 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →