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| Sponsors and Collaborators: |
University of Washington Procter and Gamble |
|---|---|
| Information provided by: | University of Washington |
| ClinicalTrials.gov Identifier: | NCT00391651 |
Purpose
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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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.
| Condition | Intervention | Phase |
|---|---|---|
|
Urinary Tract Infection |
Drug: Nitrofurantoin 100mg twice daily x 5 days Drug: TMP/SMX DS twice daily x 3 days |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Short Course Nitrofurantoin For Acute Cystitis |
| Enrollment: | 338 |
| Study Start Date: | January 2002 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Nitrofurantoin 100mg BID x 5 days
|
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
|
|
2: Active Comparator
TMP/SMX DS BID x 3 days
|
Drug: TMP/SMX DS twice daily x 3 days
TMP/SMX DS twice daily x 3 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Washington | |
| University of WA | |
| Seattle, Washington, United States, 98195 | |
| Principal Investigator: | Walter E Stamm, M.D. | University of Washington |
| Principal Investigator: | Kalpana Gupta, M.D. | Yale University |
More Information
| Responsible Party: | University Of Washington ( Ann Stapleton, MD ) |
| Study ID Numbers: | 01-1002A |
| Study First Received: | October 20, 2006 |
| Last Updated: | August 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00391651 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
UTI |
|
Cystocele Nitrofurantoin Urologic Diseases Urinary Bladder Diseases |
Urinary Tract Infections Cystitis Anti-Infective Agents, Urinary Trimethoprim-Sulfamethoxazole Combination |
|
Anti-Infective Agents Nitrofurantoin Urologic Diseases Therapeutic Uses Urinary Bladder Diseases Urinary Tract Infections |
Cystitis Anti-Infective Agents, Urinary Renal Agents Infection Pharmacologic Actions |
