Single Dose Monurol for Treatment of Acute Cystitis

June 2, 2023 updated by: Ann Stapleton, University of Washington

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the tolerance of a single does of fosfomycin
Time Frame: 28-30 days post therapy
28-30 days post therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2009

Primary Completion (Actual)

December 27, 2016

Study Completion (Actual)

December 27, 2016

Study Registration Dates

First Submitted

September 11, 2009

First Submitted That Met QC Criteria

September 14, 2009

First Posted (Estimated)

September 15, 2009

Study Record Updates

Last Update Posted (Actual)

June 5, 2023

Last Update Submitted That Met QC Criteria

June 2, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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