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

This study has been withdrawn prior to recruitment.

( recruitment failed )

First Received: August 8, 2006 Last Updated: March 1, 2007 History of Changes

Sponsor:	HaEmek Medical Center, Israel
Collaborator:	Clalit Health Services
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00361998

Purpose

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.

Condition	Intervention	Phase
Cystitis	Drug: NITROFURANTOIN MACROCRYSTALS	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Bio-equivalence Study
Official Title:	Nitrofurantoin Macrocrystals 3 Days Vs. 7 Days in the Treatment of Women With Uncomplicated Cystitis

Resource links provided by NLM:

Drug Information available for: Nitrofurantoin Nitrofurantoin monohydrate

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

Microbiological efficacy

Secondary Outcome Measures:

Clinical efficacy and side effects

Estimated Enrollment:	400
Study Start Date:	September 2006
Estimated Study Completion Date:	January 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Premenopausal healthy women
Uncomplicated cystitis

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361998

Locations

Israel
Research Unit, Clalit Health Services, Haifa and Western Galillee District
Haifa, Israel, 35024

Sponsors and Collaborators

HaEmek Medical Center, Israel

Clalit Health Services

Investigators

Principal Investigator:	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.

More Information

No publications provided

Study ID Numbers:	0706
Study First Received:	August 8, 2006
Last Updated:	March 1, 2007
ClinicalTrials.gov Identifier:	NCT00361998 History of Changes
Health Authority:	Israel: Ethics Commission

Keywords provided by HaEmek Medical Center, Israel:

Uncomplicated Cystitis
Nitrofurantoin Macrocrystals

Additional relevant MeSH terms:

Anti-Infective Agents
Nitrofurantoin
Urologic Diseases
Therapeutic Uses
Urinary Bladder Diseases

Cystitis
Anti-Infective Agents, Urinary
Renal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009