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Single Dose Monurol for Treatment of Acute Cystitis

NCT00976963 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-06-05

Study results available
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Summary

Urinary tract infecton (UTI) is a very common problem in young healthy women, afflicting approximately one-half of women by their late 20's. One of the most common antibiotics used to treat UTIs is Trimethoprim-Sulfamethoxazole (TMP-SMX), usually for total of three days. However, concerns about increased antibiotic resistance have led to increased interest in studying other antibiotics for UTI.

An alternative antibiotic which is also FDA approved for the treatment of UTIs is fosfomycin (Monurol). The effectiveness of fosfomycin in curing UTIs when given as a single dose is not well studied. The purpose of this research study is to determine what the cure rates are with a single dose of fosfomycin versus the more standard 3-day course of TMP-SMX.

Conditions

Interventions

DRUG

TMP/SMX

Take one twice daily for 3 days for urinary tract infection

DRUG

Fosfomycin

Mix sachet with 1/2 glass cold water and stir. Drink immediately

Sponsors & Collaborators

Principal Investigators

  • Ann E. Stapleton, M.D. · University of WA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-17
Primary Completion
2016-12-27
Completion
2016-12-27

Countries

  • United States

Study Locations

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Diseases
Companies

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 NCT00976963 on ClinicalTrials.gov