NCT00361998

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2006

Completed
23 days until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 2, 2007

Status Verified

March 1, 2007

First QC Date

August 8, 2006

Last Update Submit

March 1, 2007

Conditions

Cystitis

Keywords

Uncomplicated CystitisNitrofurantoin Macrocrystals

Outcome Measures

Primary Outcomes (1)

  • Microbiological efficacy

Secondary Outcomes (1)

  • Clinical efficacy and side effects

Interventions

NITROFURANTOIN MACROCRYSTALSDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Premenopausal healthy women
  • Uncomplicated cystitis

You may not qualify if:

  • Postmenopausal women
  • Complicated UTI
  • Women with catheter
  • Women with recurrent UTI
  • Pregnancy
  • Diabetes Mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Haifa, 35024, Israel

Location

MeSH Terms

Conditions

Cystitis

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Raul Raz, M.D.

    Infectious Diseases Unit, HaEmek Medical Center, Afula, Israel

    PRINCIPAL INVESTIGATOR

  • Uzi Milman, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2006

First Posted

August 9, 2006

Study Start

September 1, 2006

Study Completion

January 1, 2007

Last Updated

March 2, 2007

Record last verified: 2007-03

Locations

IL(1)