Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vag... | NCT00787553

Studies
Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy

NCT00787553

Sponsor

University of Campinas, Brazil

Status

Unknown status

Last Update Posted

Nov 7, 2008Estimated

Enrollment

75Actual

Phase

Not Applicable

Conditions

Hysterectomy

Interventions

cefazolin
tinidazole
cefazolin plus tinidazole

Countries

Brazil

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

Nov 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Nov 6, 2008

First Submission Date that Met QC Criteria

Nov 6, 2008

First Posted Date

Nov 7, 2008Estimated

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

Nov 6, 2008

Last Update Posted Date

Nov 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Detailed Description

A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil, to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
cefazolin	Active Comparator	Drug: cefazolin
tinidazole	Active Comparator	Drug: tinidazole
cefazolin plus tinidazole	Active Comparator	Drug: cefazolin plus tinidazole

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cefazolin	Drug	2.0 g, IV, 2 hours before surgery	cefazolin
tinidazole

Measure	Description	Time Frame
Post-operative infection		one month after surgery

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women undergoing to hysterectomy due to non-oncologic causes

Exclusion Criteria:

previous pelvic infection
antibiotic use within 7 days before surgery
study drugs allergy
immuno-incompetence
urinary tract infection

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

32 Years

Maximum Age

72 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jose A Simoes, MD, PhD	University of Campinas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Campinas		Campinas	São Paulo	13083-970	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D016585	Vaginosis, Bacterial

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D014627	Vaginitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002437	Cefazolin
D014011	Tinidazole
D007093	Imidazoles

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930

Browse Leaves

Not provided

Browse Branches

Not provided