Single Dose Monurol for Treatment of Acute Cystitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-17

Study Completion Date

2016-12-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Urinary Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TMP/SMX

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

Group Type ACTIVE_COMPARATOR

TMP/SMX

Intervention Type DRUG

Take one twice daily for 3 days for urinary tract infection

Fosfomycin

3g sachet single dose

Group Type EXPERIMENTAL

Fosfomycin

Intervention Type DRUG

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

Interventions

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TMP/SMX

Take one twice daily for 3 days for urinary tract infection

Intervention Type DRUG

Fosfomycin

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

Intervention Type DRUG

Other Intervention Names

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Septra Bactrim Monurol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes