Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis

NCT ID: NCT00361998

Last Updated: 2007-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-01-31

Brief Summary

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Our guidelines in the community recommend the use of NM for the treatment of women with community acquired UTI. While the length of treatment for uncomplicated cystitis with quinolones or TMP-SMX is three days, NM is recommended for seven days. However, there are not sufficient papers that establish the optimal length of treatment with NM in this population. The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI.

Detailed Description

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The aim of this proposal is to evaluate and compare NM 3 day vs. 7 day treatment for the treatment of women with uncomplicated UTI. Our design is to enroll 400 women with uncomplicated cystitis and divided according to a double-blind randomization in two groups (3 days vs. 7 days). The women will be followed 7 days and 28 days clinically and bacteriologically.

Conditions

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Cystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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NITROFURANTOIN MACROCRYSTALS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Premenopausal healthy women
2. Uncomplicated cystitis

Exclusion Criteria

1. Postmenopausal women
2. Complicated UTI
3. Women with catheter
4. Women with recurrent UTI
5. Pregnancy
6. Diabetes Mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Clalit Health Services

OTHER

Sponsor Role collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Principal Investigators

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Raul Raz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel

Uzi Milman, M.D.

Role: PRINCIPAL_INVESTIGATOR

Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.

Locations

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Research Unit, Clalit Health Services, Haifa and Western Galillee District

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0706

Identifier Type: -

Identifier Source: org_study_id

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