Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Com... | NCT01919593

Studies
Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children

NCT01919593

Sponsor

Thammasat University

Status

Completed

Last Update Posted

Aug 13, 2013Estimated

Enrollment

1,269Actual

Phase

Phase 4

Conditions

Bacteremia

Interventions

2% chlorhexidine gluconate in 70% alcohol
10%povidone iodine

Countries

Thailand

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Dec 2012Actual

Completion Date

Apr 2013Actual

First Submitted Date

Aug 6, 2013

First Submission Date that Met QC Criteria

Aug 6, 2013

First Posted Date

Aug 9, 2013Estimated

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

Aug 9, 2013

Last Update Posted Date

Aug 13, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Auchara Tangsathapornpong, Associate Professor, Thammasat UniversityPrincipal Investigator

Lead Sponsor

Thammasat UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.

Detailed Description

This is a prospective study of pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit at a tertiary-care teaching hospital. Patients who needed percutaneous blood cultures were eligible for enrollment and were classified into two groups according to antiseptic used: 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months. Blood cultures were taken primarily by ward nurses using standard technique. The blood cultures were analysed and monitored for 5 days. Isolated organisms and their antimicrobial susceptibilities were determined using standard microbiologic techniques.

Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data. A blood culture was classified as contaminated if common skin flora such as Coagulase negative staphylococci, Corynebacterium spp., Micrococcus spp., or Bacillus spp. were isolated from one of the blood culture samples without isolation of the same organism from another potential infection site (for example, intravenous catheter), or a common skin flora was isolated in a patient with incompatible clinical features and improved without specific treatment for that organism.

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

1,269Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2% Chlorhexidine Gluconate	Experimental	apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture	Drug: 2% chlorhexidine gluconate in 70% alcohol
10% povidone iodine	Active Comparator	apply 10% povidone iodine on the skin before venipuncture	Drug: 10%povidone iodine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
2% chlorhexidine gluconate in 70% alcohol	Drug	skin preparation before venipuncture for blood culture in even month	2% Chlorhexidine Gluconate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine	Pediatric patients who needed percutaneous blood cultures were recruited and were assigned 10% povidone iodine in odd months and 2% chlorhexidine gluconate in 70% alcohol in even months as an antiseptic for blood cultures. Blood culture isolates were categorized into two groups including a true pathogen and a contaminant by clinical criteria combined with laboratory data.	5 days

Secondary Outcomes

Measure	Description	Time Frame
safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine	direct observe skin reaction after use both antiseptics	48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients between 0-15 years of age who were admitted in three pediatric wards: general pediatric ward aged <5 years, general pediatric ward aged >5 years, and pediatric intensive care unit. Patients who needed percutaneous blood cultures were eligible for enrollment.

Exclusion Criteria:

Preterm infant
Patient who had skin infection at site of venepuncture
Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Auchara Tangsathapornponng, MD	Faculty of Medicine, Thammasat University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thammasat University hospital		Klong Luang	Pathumthanii	10900	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D016470	Bacteremia

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D018805	Sepsis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C010882	chlorhexidine gluconate
D000431	Ethanol
D011206	Povidone-Iodine

Ancestor Terms

ID	Term
D000438	Alcohols
D009930	Organic Chemicals
D007466	Iodophors
D017613	Iodine Compounds

Browse Leaves

Not provided

Browse Branches

Not provided