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Single Dose Monurol for Treatment of Acute Cystitis

Primary Purpose

Urinary Tract Infection

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMP/SMX
Fosfomycin
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Tract Infection focused on measuring UTI

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

TMP/SMX

Fosfomycin

Arm Description

Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days

3g sachet single dose

Outcomes

Primary Outcome Measures

Number of Participants Who Were Cured
Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.

Secondary Outcome Measures

Full Information

First Posted
September 11, 2009
Last Updated
June 2, 2023
Sponsor
University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT00976963
Brief Title
Single Dose Monurol for Treatment of Acute Cystitis
Official Title
Single Dose Monurol for Treatment of Acute Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2009 (Actual)
Primary Completion Date
December 27, 2016 (Actual)
Study Completion Date
December 27, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington

4. Oversight

Data Monitoring Committee
No

5. 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-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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection
Keywords
UTI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TMP/SMX
Arm Type
Active Comparator
Arm Description
Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days
Arm Title
Fosfomycin
Arm Type
Experimental
Arm Description
3g sachet single dose
Intervention Type
Drug
Intervention Name(s)
TMP/SMX
Other Intervention Name(s)
Septra, Bactrim
Intervention Description
Take one twice daily for 3 days for urinary tract infection
Intervention Type
Drug
Intervention Name(s)
Fosfomycin
Other Intervention Name(s)
Monurol
Intervention Description
Mix sachet with 1/2 glass cold water and stir. Drink immediately
Primary Outcome Measure Information:
Title
Number of Participants Who Were Cured
Description
Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.
Time Frame
28-30 days post therapy

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann E. Stapleton, M.D.
Organizational Affiliation
University of WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Single Dose Monurol for Treatment of Acute Cystitis

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