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Single Dose Monurol for Treatment of Acute Cystitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Washington
Sponsor:
Information provided by (Responsible Party):
Ann Stapleton, University of Washington
ClinicalTrials.gov Identifier:
NCT00976963
First received: September 11, 2009
Last updated: June 3, 2014
Last verified: June 2014
  Purpose

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 Intervention
Urinary Tract Infection
Drug: Fosfomycin
Drug: TMP/SMX DS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Single Dose Monurol for Treatment of Acute Cystitis

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • To assess the efficacy of a single dose fosfomycin [ Time Frame: 28-30 post therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To assess the tolerance of a single does of fosfomycin [ Time Frame: 28-30 days post therapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: September 2009
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fosfomycin
Mix sachet with 1/2 glass cold water and stir. Drink immediatley
Drug: Fosfomycin
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

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00976963

Contacts
Contact: Niki DeShaw, Study Coord. 206-685-1048 ndeshaw@u.washington.edu
Contact: Ellen Cassen, Nurse Pract. 206-685-1048 ecassen@u.washington.edu

Locations
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Niki DeShaw, Study Coord    206-685-1048    ndeshaw@u.washington.edu   
Principal Investigator: Ann E Stapleton, M.D.         
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Ann E. Stapleton, M.D. University of WA
  More Information

No publications provided

Responsible Party: Ann Stapleton, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00976963     History of Changes
Other Study ID Numbers: 34776-B
Study First Received: September 11, 2009
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
UTI

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014