Single Dose Monurol for Treatment of Acute Cystitis

Urinary Tract Infection Clinical Trial

Official title:

Single Dose Monurol for Treatment of Acute Cystitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00976963
• Other study ID #: 34776
• Status: Completed
• Phase: N/A
• Start date: September 17, 2009
• Est. completion date: December 27, 2016

Study information

• Verified date: June 2023
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 27, 2016
• Est. primary completion date: December 27, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• TMP/SMX
Take one twice daily for 3 days for urinary tract infection
• Fosfomycin
Mix sachet with 1/2 glass cold water and stir. Drink immediately

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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