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Single Dose Monurol for Treatment of Acute Cystitis

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00976963
First Posted: September 15, 2009
Last Update Posted: November 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ann Stapleton, University of Washington
  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
Intervention Model: Parallel Assignment
Masking: None (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 Ann Stapleton, University of Washington:

Primary Outcome Measures:
  • To assess the efficacy of a single dose fosfomycin [ Time Frame: 28-30 post therapy ]

Secondary Outcome Measures:
  • To assess the tolerance of a single does of fosfomycin [ Time Frame: 28-30 days post therapy ]

Enrollment: 300
Study Start Date: September 2009
Estimated Study Completion Date: May 30, 2018
Primary Completion Date: June 2017 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

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


Locations
United States, Washington
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
  More Information

Responsible Party: Ann Stapleton, Professor, Medicine, Infectious Diseases, University of Washington
ClinicalTrials.gov Identifier: NCT00976963     History of Changes
Other Study ID Numbers: 34776
First Submitted: September 11, 2009
First Posted: September 15, 2009
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ann Stapleton, University of Washington:
UTI

Additional relevant MeSH terms:
Urinary Tract Infections
Cystitis
Infection
Urologic Diseases
Urinary Bladder Diseases
Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents