Single Dose Monurol for Treatment of Acute Cystitis
Information source: University of Washington
Information obtained from ClinicalTrials.gov on October 19, 2009
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):
Watler E. Stamm, 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: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
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
Walter E Stamm, M.D., Principal Investigator
Additional Information
Starting date: September 2009
Ending date: June 2011
Last updated: September 14, 2009
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