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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01919593 |
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Date of registration:
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06/08/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
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Scientific title:
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The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients |
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Date of first enrolment:
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January 2012 |
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Target sample size:
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1269 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01919593 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Auchara Tangsathapornponng, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty of Medicine, Thammasat University |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bacteremia
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Intervention(s)
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Drug: 2% chlorhexidine gluconate in 70% alcohol
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Drug: 10%povidone iodine
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Primary Outcome(s)
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efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
[Time Frame: 5 days]
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Secondary Outcome(s)
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safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine
[Time Frame: 48 hours]
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Secondary ID(s)
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MTU-PE-3-053/55
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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