NCT00391651

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 They will then be treated with another standard antibiotic at no cost to them and will be withdrawn from the study at that time.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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
338

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2002

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2002

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

3.5 years

First QC Date

October 20, 2006

Last Update Submit

June 3, 2014

Conditions

Urinary Tract Infection

Keywords

UTI

Outcome Measures

Primary Outcomes (1)

  • Microbiological Cure

    28-30 days post therapy

Study Arms (2)

1

ACTIVE COMPARATOR

Nitrofurantoin 100mg BID x 5 days

Drug: Nitrofurantoin 100mg twice daily x 5 daysDrug: 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

Interventions

Nitrofurantoin 100mg twice daily x 5 daysDRUG

Nitrofurantoin 100mg twice daily x 5 days

Also known as: Macrobid
1
TMP/SMX DS twice daily x 3 daysDRUG

TMP/SMX DS twice daily x 3 days

Also known as: Septra
12

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of WA

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • 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.

    PMID: 17998493RESULT

MeSH Terms

Conditions

Urinary Tract Infections

Interventions

NitrofurantoinTrimethoprim, Sulfamethoxazole Drug Combination

Condition Hierarchy (Ancestors)

InfectionsUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfamethoxazoleBenzenesulfonamidesSulfonamidesAmidesSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsTrimethoprimPyrimidinesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Walter E Stamm, M.D.

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Kalpana Gupta, M.D.

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 20, 2006

First Posted

October 24, 2006

Study Start

January 1, 2002

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations

US(1)