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COMPLETED Phase 3

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

NCT03357614 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,395 participants
Start Date 2018-09-18
Est. Completion 2019-12-14
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03357614

The ClinicalTrials.gov registry entry for NCT03357614 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,395 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 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03357614 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Other, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03357614?

This trial is sponsored by Iterum Therapeutics, International Limited, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial