NCT00391651

Short Course Nitrofurantoin for Acute Cystitis

Short Course Nitrofurantoin For Acute Cystitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 338 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. 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 sample and then randomly assigned to one of the two treatment groups. will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.

Detailed description

The purpose of this research study is to determine what the cure rates are with a 5 day course of nitrofurantoin versus the more standard 3 day course of trimethoprim/sulfamethoxazone. The study will improve our knowledge of which antibiotic and what length of therapy is best for treatment of UTI, taking into account the problem of antibiotic resistance. 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 sample and then randomly assigned to one of the two treatment groups. The randomization is generated by a Research Scientist working with the study. They will be given a sheet to record symptoms at home. They will be asked to return to the clinic in 5-9 and 28-30 days after completing antibiotic therapy. Urine cultures will be obtained at each visit. If they were assigned to the nitrofurantoin treatment regimen, they will also be asked to collect a urine sample at home on the third day. If the subject develops recurrent urinary symptoms or does not have resolution of symptoms after completing the initial treatment course, they will be asked to return to the clinic and provide another urine sample for analysis. They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time. The study population is women ages 18-45 with acute symptoms of a UTI without a history of UTI in the past 6 weeks.

Conditions

• Urinary Tract Infection

Interventions

Type	Name	Description
DRUG	Nitrofurantoin 100mg twice daily x 5 days	Nitrofurantoin 100mg twice daily x 5 days
DRUG	TMP/SMX DS twice daily x 3 days	TMP/SMX DS twice daily x 3 days

Timeline

• Start date: 2002-01-01
• Primary completion: 2005-07-01
• Completion: 2005-07-01
• First posted: 2006-10-24
• Last updated: 2014-06-05

Locations

1 site across 1 country: United States