Nitrofurantoin Macrocrystals 3 Days Versus 7 Days in the... | NCT00361998

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

NCT00361998

Sponsor

HaEmek Medical Center, Israel

Status

Withdrawn

Last Update Posted

Mar 2, 2007Estimated

Enrollment

400

Phase

Phase 4

Conditions

Cystitis

Interventions

NITROFURANTOIN MACROCRYSTALS

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

recruitment failed

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Jan 2007

First Submitted Date

Aug 8, 2006

First Submission Date that Met QC Criteria

Aug 8, 2006

First Posted Date

Aug 9, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2007

Last Update Posted Date

Mar 2, 2007Estimated

Name	Class
Clalit Health Services	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400

Name	Type	Description	Arm Group Labels	Other Names
NITROFURANTOIN MACROCRYSTALS	Drug

Measure	Description	Time Frame
Microbiological efficacy

Measure	Description	Time Frame
Clinical efficacy and side effects

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Unit, Clalit Health Services, Haifa and Western Galillee District		Haifa		35024	Israel

Condition Browse Module

MeSH Terms

ID	Term
D003556	Cystitis

Ancestor Terms

ID	Term
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009582	Nitrofurantoin

Ancestor Terms

ID	Term
D009581	Nitrofurans
D009574	Nitro Compounds
D009930	Organic Chemicals
D005663	Furans

Browse Leaves

Not provided

Browse Branches

Not provided