Single Dose Monurol for Treatment of Acute Cystitis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single Dose Monurol for Treatment of Acute Cystitis

Conditions
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Urinary Tract Infection

Intervention / Treatment
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* Drug: TMP/SMX
* Drug: Fosfomycin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TMP/SMX<br>Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days | Drug: TMP/SMX<br>* Take one twice daily for 3 days for urinary tract infection<br>* Other names: Bactrim;|
| Experimental: Fosfomycin<br>3g sachet single dose | Drug: Fosfomycin<br>* Mix sachet with 1/2 glass cold water and stir. Drink immediately<br>* Other names: Monurol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were Cured | Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach. | 28-30 days post therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UTI