Single Dose Monurol for Treatment of Acute Cystitis

NCT00976963 | Completed Results

• 1 other identifier: 34776
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection

Keywords

UTI

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Were Cured

  Cure as defined by no further treatment for subsequent or unresolved symptoms, by modified ITT approach.

  28-30 days post therapy

Study Arms (2)

TMP/SMX

ACTIVE COMPARATOR

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

Drug: TMP/SMX

Fosfomycin

EXPERIMENTAL

3g sachet single dose

Drug: Fosfomycin

Interventions

TMP/SMX DRUG

Take one twice daily for 3 days for urinary tract infection

Also known as: Septra, Bactrim

TMP/SMX

Fosfomycin DRUG

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

Also known as: Monurol

Fosfomycin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Non pregnant women in good health with symptoms of acute cystitis for less than 7 days

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Fosfomycin

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Organophosphonates; Organophosphorus Compounds

Limitations and Caveats

The clinicians and participants were not blinded as to the assigned intervention.

Results Point of Contact

• Title: Ann Stapleton
• Organization: University of Washington

stapl@uw.edu

‪(206) 880-3464‬

Study Officials

• Ann E. Stapleton, M.D.

  University of WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medicine, Infectious Diseases

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 15, 2009
• Study Start: September 17, 2009
• Primary Completion: December 27, 2016
• Study Completion: December 27, 2016
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)