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

Primary Purpose

Cystitis

Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
NITROFURANTOIN MACROCRYSTALS
Sponsored by
HaEmek Medical Center, Israel
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystitis focused on measuring Uncomplicated Cystitis, Nitrofurantoin Macrocrystals

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Premenopausal healthy women Uncomplicated cystitis Exclusion Criteria: Postmenopausal women Complicated UTI Women with catheter Women with recurrent UTI Pregnancy Diabetes Mellitus

Sites / Locations

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

Outcomes

Primary Outcome Measures

Microbiological efficacy

Secondary Outcome Measures

Clinical efficacy and side effects

Full Information

First Posted
August 8, 2006
Last Updated
March 1, 2007
Sponsor
HaEmek Medical Center, Israel
Collaborators
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT00361998
Brief Title
Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the Treatment of Women With Uncomplicated Cystitis
Official Title
Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Withdrawn
Why Stopped
recruitment failed
Study Start Date
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
HaEmek Medical Center, Israel
Collaborators
Clalit Health Services

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis
Keywords
Uncomplicated Cystitis, Nitrofurantoin Macrocrystals

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
NITROFURANTOIN MACROCRYSTALS
Primary Outcome Measure Information:
Title
Microbiological efficacy
Secondary Outcome Measure Information:
Title
Clinical efficacy and side effects

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Premenopausal healthy women Uncomplicated cystitis Exclusion Criteria: Postmenopausal women Complicated UTI Women with catheter Women with recurrent UTI Pregnancy Diabetes Mellitus
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raul Raz, M.D.
Organizational Affiliation
Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uzi Milman, M.D.
Organizational Affiliation
Research Unit, Clalit Health Services, Haifa and Western-Galilee District, Israel.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Unit, Clalit Health Services, Haifa and Western Galillee District
City
Haifa
ZIP/Postal Code
35024
Country
Israel

12. IPD Sharing Statement

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

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