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

NCT03357614 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1395

Last updated 2020-12-29

Study results available
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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.

Conditions

  • Complicated Urinary Tract Infections

Interventions

DRUG

Sulopenem

Antibiotic therapy for complicated UTI

DRUG

Sulopenem-Etzadroxil/Probenecid

Antibiotic therapy for complicated UTI

DRUG

Ertapenem

Antibiotic therapy for complicated UTI

DRUG

Ciprofloxacin

Antibiotic therapy for complicated UTI

DRUG

Amoxicillin-clavulanate

Antibiotic therapy for complicated UTI

Sponsors & Collaborators

  • Iterum Therapeutics, International Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-18
Primary Completion
2019-12-14
Completion
2019-12-14
FDA Drug
Yes

Countries

  • United States
  • Estonia
  • Georgia
  • Hungary
  • Latvia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03357614 on ClinicalTrials.gov