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Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women

A Prospective Phase 3 Randomized Multi-center Double-blind Study of Efficacy Tolerability & Safety of Oral Sulopenem-etzadroxil/Probenecid vs Ciprofloxacin for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Adult Women

NCT03354598•Iterum Therapeutics, International Limited

View on ClinicalTrials.gov

Summary

This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. Female patients ≥18 years of age with 24-96 hours of urinary symptoms attributable to a urinary tract infection (UTI)
•2. Two of the following signs and symptoms of uUTI: urinary frequency, urinary urgency, pain or burning micturition, suprapubic pain
•3. A mid-stream urine specimen with:
•1. a dipstick analysis positive for nitrite AND
•2. evidence of pyuria as defined by either:
•i. a dipstick analysis positive for leukocyte esterase ii. at least 10 white blood cells per cubic millimeter on microscopic analysis of unspun urine iii. White blood cell count ≥10 cells/high-powered field in the sediment of a spun urine
•4. Has given written informed consent to participate in the study.

Exclusion Criteria

•1. Presence of signs and symptoms suggestive of acute pyelonephritis: fever (temperature \> 38°Celsius), chills, costovertebral angle tenderness, flank pain, nausea, and/or vomiting
•2. Receipt of antibacterial drug therapy potentially effective as treatment of uUTI within the prior 7 days
•3. Concurrent use of non-study treatments that would have a potential effect on outcome evaluations in patients with uUTI
•4. Patients with ileal loops or urinary stoma
•5. Patients with an indwelling urinary catheter in the previous 30 days
•6. Patients with paraplegia
•7. Patients who are likely to receive ongoing antibacterial drug prophylaxis after treatment of uUTI (e.g., patients with vesico-ureteral reflux)
•8. Any history of trauma to the pelvis or urinary tract
•9. Patient's urine culture, if available at study entry, identify more than 2 microorganisms regardless of colony count or patient has a confirmed fungal UTI
•10. Patient is receiving hemodialysis or peritoneal dialysis or had a renal transplant
+15 more criteria

Locations (60)

Medical Facility

Birmingham, Alabama, United States

Medical Facility

Phoenix, Arizona, United States

Medical Facility

Tolleson, Arizona, United States

Medical Facility

Cerritos, California, United States

Medical Facility

Chula Vista, California, United States

Medical Facility

Fullerton, California, United States

Medical Facility

La Mesa, California, United States

Medical Facility

Los Angeles, California, United States

Medical Facility

San Diego, California, United States

Medical Facility

Sylmar, California, United States

Key Dates

Start Date

August 1, 2018

Primary Completion Date

January 16, 2020

Completion Date

January 20, 2020

Last Updated

January 12, 2021

Enrollment

1,671

ACTUAL participants

Conditions

Uncomplicated Urinary Tract Infections

Interventions

Sulopenem-Etzadroxil/Probenecid

DRUG

Ciprofloxacin

DRUG

Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg as an Analgesic for Short-Term Treatment in Female Subjects Suffering From Moderate-to-Severe Pain and Burning Upon Urination Associated With Uncomplicated Urinary Tract Infections (uUTI)

NCT01650051

Uncomplicated Urinary Tract Infections

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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