Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-25 @ 7:09 PM
Study NCT ID:
NCT01919593
Status:
COMPLETED
Last Update Posted:
2013-08-13
First Post:
2013-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016470', 'term': 'Bacteremia'}], 'ancestors': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010882', 'term': 'chlorhexidine gluconate'}, {'id': 'D000431', 'term': 'Ethanol'}, {'id': 'D011206', 'term': 'Povidone-Iodine'}], 'ancestors': [{'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007466', 'term': 'Iodophors'}, {'id': 'D017613', 'term': 'Iodine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D011145', 'term': 'Polyvinyls'}, {'id': 'D014753', 'term': 'Vinyl Compounds'}, {'id': 'D000475', 'term': 'Alkenes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011205', 'term': 'Povidone'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1269}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-09', 'studyFirstSubmitDate': '2013-08-06', 'studyFirstSubmitQcDate': '2013-08-06', 'lastUpdatePostDateStruct': {'date': '2013-08-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine', 'timeFrame': '5 days', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'safety of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine', 'timeFrame': '48 hours', 'description': 'direct observe skin reaction after use both antiseptics'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Blood culture', 'Contamination', 'Chlorhexidine gluconate', 'Povidone iodine'], 'conditions': ['Bacteremia']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of 2% chlorhexidine gluconate in 70% alcohol compared with 10% povidone iodine in reducing blood culture contamination in pediatric patients.', 'detailedDescription': '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.\n\nBlood 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Day', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Preterm infant\n* Patient who had skin infection at site of venepuncture\n* Patient who had history allergy to 2% Chlorhexidine gluconate in 70% alcohol or 10% povidone-iodine'}, 'identificationModule': {'nctId': 'NCT01919593', 'briefTitle': 'Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compare 10% Povidone Iodine in Blood Culture in Children', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'The Efficacy of 2% Chlorhexidine Gluconate in 70% Alcohol Compared With 10% Povidone Iodine in Reducing Blood Culture Contamination in Pediatric Patients', 'orgStudyIdInfo': {'id': 'MTU-PE-3-053/55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% Chlorhexidine Gluconate', 'description': 'apply 2% Chlorhexidine Gluconate in 70% Alcohol on skin before venipuncture', 'interventionNames': ['Drug: 2% chlorhexidine gluconate in 70% alcohol']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10% povidone iodine', 'description': 'apply 10% povidone iodine on the skin before venipuncture', 'interventionNames': ['Drug: 10%povidone iodine']}], 'interventions': [{'name': '2% chlorhexidine gluconate in 70% alcohol', 'type': 'DRUG', 'otherNames': ['Chloraprep'], 'description': 'skin preparation before venipuncture for blood culture in even month', 'armGroupLabels': ['2% Chlorhexidine Gluconate']}, {'name': '10%povidone iodine', 'type': 'DRUG', 'otherNames': ['Betadine'], 'description': 'skin preparation before venipuncture for blood culture in odd month', 'armGroupLabels': ['10% povidone iodine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10900', 'city': 'Klong Luang', 'state': 'Pathumthanii', 'country': 'Thailand', 'facility': 'Thammasat University hospital'}], 'overallOfficials': [{'name': 'Auchara Tangsathapornponng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Thammasat University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Auchara Tangsathapornpong', 'investigatorAffiliation': 'Thammasat University'}}}}