Short Course Nitrofurantoin for Acute Cystitis

NCT ID: NCT00391651

Last Updated: 2014-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-01-31
• Study Completion Date: 2005-07-31

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Nitrofurantoin 100mg BID x 5 days

Group Type: ACTIVE_COMPARATOR

Nitrofurantoin 100mg twice daily x 5 days

Intervention Type: DRUG

Nitrofurantoin 100mg twice daily x 5 days

TMP/SMX DS twice daily x 3 days

Intervention Type: DRUG

TMP/SMX DS twice daily x 3 days

2

TMP/SMX DS BID x 3 days

Group Type: ACTIVE_COMPARATOR

TMP/SMX DS twice daily x 3 days

Intervention Type: DRUG

TMP/SMX DS twice daily x 3 days

Interventions

Nitrofurantoin 100mg twice daily x 5 days

Nitrofurantoin 100mg twice daily x 5 days

Intervention Type: DRUG

TMP/SMX DS twice daily x 3 days

TMP/SMX DS twice daily x 3 days

Intervention Type: DRUG

Other Intervention Names

Macrobid; Septra

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Procter and Gamble

INDUSTRY

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Ann Stapleton

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Walter E Stamm, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Kalpana Gupta, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

University of WA

Seattle, Washington, United States

Countries

United States

References

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. doi: 10.1001/archinte.167.20.2207.

Reference Type: RESULT

PMID: 17998493 (View on PubMed)

Other Identifiers

01-1002-A 07

Identifier Type: -

Identifier Source: secondary_id

20580-A

Identifier Type: -

Identifier Source: org_study_id