Single Dose Monurol for Treatment of Acute Cystitis

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.

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

About this study

Procedures subjects will undergo once they have read and signed the consent are:

Questions about their medical and sexual history and current symptoms of UTI. They will be asked to provide a urine and peri-urethral sample and then are randomly assigned to one of the two treatment groups.They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-8 and 28-30 days after completing antibiotic therapy.Follow-up questions will be asked and urine and peri-urethral will be self collected at each visit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Non pregnant women in good health with symptoms of acute cystitis for less than 7 days

Exclusion criteria

Pregnant, lactating, or not regularly contracepting
History of chronic conditions such as diabetes
Known anatomic abnormalities of the urinary tract
Use of prophylactic antibiotics
History of allergy or intolerance to any of the study drugs
Recent (> 2 weeks)exposure to oral or parenteral antimicrobial
History of UTI in previous 1 month

Treatment and study plan

TMP/SMX

Drug

Take one twice daily for 3 days for urinary tract infection

Other names: Septra, Bactrim

Fosfomycin

Drug

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

Other names: Monurol

Primary outcomes

Number of Participants Who Were Cured

Time frame: 28-30 days post therapy

Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2016
First posted: Sep 15, 2009
Registry last updated: Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed