Single Dose Monurol for Treatment of Acute Cystitis

University of Washington

Status: Completed

Conditions: Urinary Tract Infection

Treatments: Drug: TMP/SMX; Drug: Fosfomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00976963

34776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

TMP/SMX

Active Comparator group

Description:

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

Treatment:

Drug: TMP/SMX

Fosfomycin

Experimental group

Description:

3g sachet single dose

Treatment:

Drug: Fosfomycin