NCT00976963

Single Dose Monurol for Treatment of Acute Cystitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2009-09-17
• Primary completion: 2016-12-27
• Completion: 2016-12-27
• First posted: 2009-09-15
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

1 site across 1 country: United States