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Single Dose Monurol for Treatment of Acute Cystitis

Information source: University of Washington
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Tract Infection

Intervention: Fosfomycin (Drug); TMP/SMX DS (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of Washington

Official(s) and/or principal investigator(s):
Ann E. Stapleton, M.D., Principal Investigator, Affiliation: University of WA

Overall contact:
Niki DeShaw, Study Coord., Phone: 206-685-1048, Email: ndeshaw@u.washington.edu

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-sulfa (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.

Clinical Details

Official title: Single Dose Monurol for Treatment of Acute Cystitis

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To assess the efficacy of a single dose fosfomycin

Secondary outcome: To assess the tolerance of a single does of fosfomycin

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Niki DeShaw, Study Coord., Phone: 206-685-1048, Email: ndeshaw@u.washington.edu

University of Washington, Seattle, Washington 98195, United States; Recruiting
Niki DeShaw, Study Coord, Phone: 206-685-1048, Email: ndeshaw@u.washington.edu
Ann E Stapleton, M.D., Principal Investigator
Additional Information

Starting date: September 2009
Last updated: June 3, 2014

Page last updated: August 23, 2015

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