Single Dose Monurol for Treatment of Acute Cystitis
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|ClinicalTrials.gov Identifier: NCT00976963|
Recruitment Status : Unknown
Verified November 2017 by Ann Stapleton, University of Washington.
Recruitment status was: Active, not recruiting
First Posted : September 15, 2009
Last Update Posted : November 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Urinary Tract Infection||Drug: Fosfomycin Drug: TMP/SMX DS||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Dose Monurol for Treatment of Acute Cystitis|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||May 30, 2018|
Active Comparator: Fosfomycin
Mix sachet with 1/2 glass cold water and stir. Drink immediatley
3g sachet single dose
Other Name: Monurol
Active Comparator: TMP/SMX
Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab (TMP/SMX) Take one twice daily for 3 days for urinary tract infection
Drug: TMP/SMX DS
160/800mg BID x 3 days
Other Name: Septra
- To assess the efficacy of a single dose fosfomycin [ Time Frame: 28-30 post therapy ]
- To assess the tolerance of a single does of fosfomycin [ Time Frame: 28-30 days post therapy ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00976963
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195|
|Principal Investigator:||Ann E. Stapleton, M.D.||University of WA|