- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00976963
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: TMP/SMX
Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days
|
Take one twice daily for 3 days for urinary tract infection
Other Names:
|
Experimental: Fosfomycin
3g sachet single dose
|
Mix sachet with 1/2 glass cold water and stir.
Drink immediately
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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28-30 days post therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the tolerance of a single does of fosfomycin
Time Frame: 28-30 days post therapy
|
28-30 days post therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ann E. Stapleton, M.D., University of WA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 34776
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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