Clinical trial NCT01919593: Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
Official title: The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacteremia
Keywords: Blood culture
Contamination
Chlorhexidine gluconate
Povidone iodine
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2013-08-09
Enrollment: 1269
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
timeFrame: 5 days
Secondary outcomes:
measure: safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
timeFrame: 48 hours
Other outcomes:
Locations:
city: Klong luang
country: Thailand
facility: Thammasat University hospital
state: Pathumthanii
Study officials:
affiliation: Faculty of Medicine, Thammasat University
name: Auchara Tangsathapornponng, MD
role: PRINCIPAL_INVESTIGATOR
References: