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

Bacteremia Clinical Trial

Official title:

The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01919593
• Other study ID #: MTU-PE-3-053/55
• Status: Completed
• Phase: Phase 4
• First received: August 6, 2013
• Last updated: August 9, 2013
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: August 2013
• Source: Thammasat University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1269
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteremia

Intervention

Drug:
• 2% chlorhexidine gluconate in 70% alcohol
skin preparation before venipuncture for blood culture in even month
• 10%povidone iodine
skin preparation before venipuncture for blood culture in odd month

Locations

Country	Name	City	State
Thailand	Thammasat University hospital	Klong luang	Pathumthanii

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine	direct observe skin reaction after use both antiseptics	48 hours	Yes