Single Dose Monurol for Treatment of Acute Cystitis - Full Text View

Sponsor:	University of Washington
Collaborator:	Forest Laboratories
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00976963

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:

MedlinePlus related topics: Antibiotics Urinary Tract Infections

Drug Information available for: Fosfomycin Fosfomycin tromethamine

U.S. FDA Resources

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:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Fosfomycin	Drug: Fosfomycin 3g sachet single dose Other Name: Monurol
Active Comparator: TMP/SMX	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

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

Locations

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

Sponsors and Collaborators

University of Washington

Forest Laboratories

Investigators

Principal Investigator:

Ann E. Stapleton, M.D.

University of WA

More Information

No publications provided

Responsible Party:	Ann Stapleton, MD, University of WA
ClinicalTrials.gov Identifier:	NCT00976963 History of Changes
Other Study ID Numbers:	34776-B
Study First Received:	September 11, 2009
Last Updated:	March 30, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

UTI

Additional relevant MeSH terms:

Cystitis
Urinary Tract Infections
Urinary Bladder Diseases
Urologic Diseases
Infection

Fosfomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012