Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03357614 · ClinicalTrials.gov registry record · Phase 3
Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults
A Phase 3 study of Complicated Urinary Tract Infections, sponsored by Iterum Therapeutics, International Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,395
- Enrollment target
- 20
- Study locations
NCT03357614: Completed Phase 3 study of Complicated Urinary Tract Infections, sponsored by Iterum Therapeutics, International Limited.
NCT03357614 is a Phase 3 study of Complicated Urinary Tract Infections that has completed, run by Iterum Therapeutics, International Limited. The registered enrollment target is 1,395 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03357614, a Phase 3 study of Complicated Urinary Tract Infections, has completed, sponsored by Iterum Therapeutics, International Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,395 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
Primary Outcome
Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to \<1000 CFU/mL)
Conditions Studied
Interventions
- DRUG Ciprofloxacin
- DRUG Amoxicillin-clavulanate
- DRUG Ertapenem
- DRUG Sulopenem-Etzadroxil/Probenecid
- DRUG Sulopenem
Study Locations (20)
California
- Medical Facility - Bellflower
- Medical Facility - Chula Vista
- Medical Facility - La Mesa
- Medical Facility - La Palma
- Medical Facility - Torrance
Other
- Medical Facility - Kohtla-Järve
- Medical Facility - Tallinn
- Medical Facility - Võru
- Medical Facility - Tbilisi
- Medical Facility - Tbilisi
Ohio
- Medical Facility - Columbus
- Medical Facility - Columbus
Texas
- Medical Facility - Dallas
- Medical Facility - Houston
Florida
- Medical Facility - Miami Lakes
Georgia
- Medical Facility - Columbus
Idaho
- Medical Facility - Idaho Falls
Massachusetts
- Medical Facility - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,395 participants |
| Start Date | 2018-09-18 |
| Est. Completion | 2019-12-14 |
| Phase | Phase 3 |
What the finished NCT03357614 record still lists
NCT03357614 is an interventional study that assigns participants to a tested intervention. Its 1,395 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% higher).
The record links to 1 condition, with Complicated Urinary Tract Infections appearing as the primary indexed condition, and to 5 interventions - of which Ciprofloxacin is the first listed.
NCT03357614 names 20 study sites across 10 states, led by California, Other, Ohio.
Frequently Asked Questions
What is clinical trial NCT03357614 about?
NCT03357614 is a clinical study titled "Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults". This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
What is the current status of trial NCT03357614?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,395 participants. The study started on 2018-09-18. Estimated completion is 2019-12-14.
What conditions does trial NCT03357614 study?
This clinical trial studies the following conditions: Complicated Urinary Tract Infections.
What interventions are being tested in trial NCT03357614?
The interventions under investigation include: Ciprofloxacin (DRUG), Amoxicillin-clavulanate (DRUG), Ertapenem (DRUG), Sulopenem-Etzadroxil/Probenecid (DRUG), Sulopenem (DRUG).
Who is sponsoring clinical trial NCT03357614?
This trial is sponsored by Iterum Therapeutics, International Limited, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03357614 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03357614's enrollment target sits among peer trials
1,395 176th of 2000 higher than 1,825 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05006131 · 1,395 participants
Pancreatic Cancer Screening for At-risk Individuals
- NCT02205762 · 1,400 participants · Phase 2
LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis
- NCT02445222 · 1,400 participants · Phase 3
CAR-T Long Term Follow Up (LTFU) Study
- NCT03145077 · 1,400 participants · NA
Dynamic Contrast-Enhanced Magnetic Resonance Imaging in Diagnosing Osteoradionecrosis in Patients With Head and Neck Cancer That Is Primary, Has Come Back, or Has Spread to Other Places in the Body
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI