Short Course Nitrofurantoin for Acute Cystitis
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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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Short Course Nitrofurantoin For Acute Cystitis |
- Microbiological Cure [ Time Frame: 28-30 days post therapy ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Active Comparator: 1
Nitrofurantoin 100mg BID x 5 days
|
Drug: Nitrofurantoin 100mg twice daily x 5 days
Nitrofurantoin 100mg twice daily x 5 days
Other Name: Macrobid
Drug: TMP/SMX DS twice daily x 3 days
TMP/SMX DS twice daily x 3 days
Other Name: Septra
|
|
Active Comparator: 2
TMP/SMX DS BID x 3 days
|
Drug: TMP/SMX DS twice daily x 3 days
TMP/SMX DS twice daily x 3 days
Other Name: Septra
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Women 18-45 years of age who were nonpregnant, in good general health, and had symptoms of acute cystitis (dysuria) and a urine culture with ³102 cfu/ml of a uropathogen
Exclusion Criteria:
- Women who were pregnant, lactating, or not regularly contracepting or with diabetes, had known anatomic abnormalities of the urinary tract, allergy to any of the study drugs, recent (<2 weeks) exposure to an oral or parenteral antimicrobial, or who were currently using prophylactic antibiotics were not eligible
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
No publications provided by University of Washington
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ann Stapleton, MD, University Of Washington |
| ClinicalTrials.gov Identifier: | NCT00391651 History of Changes |
| Other Study ID Numbers: | 20580-A, 01-1002-A 07 |
| Study First Received: | October 20, 2006 |
| Last Updated: | March 30, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Washington:
|
UTI |
Additional relevant MeSH terms:
|
Cystitis Urinary Tract Infections Urinary Bladder Diseases Urologic Diseases Infection Nitrofurantoin |
Anti-Infective Agents, Urinary Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Renal Agents |
ClinicalTrials.gov processed this record on May 23, 2013