Short Course Nitrofurantoin for Acute Cystitis - Full Text View

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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

MedlinePlus related topics:

Urinary Tract Infections

Drug Information available for:

Trimethoprim-sulfamethoxazole combination Nitrofurantoin Nitrofurantoin monohydrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Short Course Nitrofurantoin For Acute Cystitis

Further study details as provided by University of Washington:

Primary Outcome Measures:

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
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

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00391651

Locations


United States, Washington
	University of WA
	Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

Procter and Gamble

Investigators


Principal Investigator:	Walter E Stamm, M.D.	University of Washington

Principal Investigator:	Kalpana Gupta, M.D.	Yale University

More Information

Publications indexed to this study:

Gupta K, Hooton TM, Roberts PL, Stamm WE. Short-course nitrofurantoin for the treatment of acute uncomplicated cystitis in women. Arch Intern Med. 2007 Nov 12;167(20):2207-12.

Responsible Party:	University Of Washington ( Ann Stapleton, MD )
Study ID Numbers:	01-1002A
First Received:	October 20, 2006
Last Updated:	August 19, 2008
ClinicalTrials.gov Identifier:	NCT00391651
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

UTI

Study placed in the following topic categories:

Nitrofurantoin

Urologic Diseases

Urinary Bladder Diseases

Urinary Tract Infections

Cystitis

Trimethoprim-Sulfamethoxazole Combination

Additional relevant MeSH terms:

Anti-Infective Agents

Therapeutic Uses

Anti-Infective Agents, Urinary

Renal Agents

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008

Sponsors and Collaborators:	University of Washington Procter and Gamble
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00391651