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Single Dose Monurol for Treatment of Acute Cystitis

Sponsor
University of Washington (Other)
Overall Status
Unknown status
CT.gov ID
NCT00976963
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
104.9
Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Single Dose Monurol for Treatment of Acute Cystitis
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jun 1, 2017
Anticipated Study Completion Date :
May 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Fosfomycin

Mix sachet with 1/2 glass cold water and stir. Drink immediatley

Drug: Fosfomycin
3g sachet single dose
Other Names:
  • 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 Names:
  • Septra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To assess the efficacy of a single dose fosfomycin [28-30 post therapy]

    Secondary Outcome Measures

    1. To assess the tolerance of a single does of fosfomycin [28-30 days post therapy]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Washington Seattle Washington United States 98195

    Sponsors and Collaborators

    • University of Washington

    Investigators

    • Principal Investigator: Ann E. Stapleton, M.D., University of WA

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ann Stapleton, Professor, Medicine, Infectious Diseases, University of Washington
    ClinicalTrials.gov Identifier:
    NCT00976963
    Other Study ID Numbers:
    • 34776
    First Posted:
    Sep 15, 2009
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Ann Stapleton, Professor, Medicine, Infectious Diseases, University of Washington
    UTI
    Additional relevant MeSH terms:
    Urinary Tract Infections
    Cystitis
    Fosfomycin

    Study Results

    No Results Posted as of Nov 17, 2017