Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT00549393
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2007-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D007049', 'term': 'Iatrogenic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amilsto1@jhmi.edu', 'phone': '4106143917', 'title': 'Dr. Aaron Milstone', 'organization': 'Johns Hopkins University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'participants were followed for the duration of ICU stay, median stay 3 days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Daily bathing with 2% chlorhexidine gluconate\n\n2% Chlorhexidine gluconate cloth: Daily bathing', 'otherNumAtRisk': 2422, 'otherNumAffected': 43, 'seriousNumAtRisk': 2422, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Standard bathing with soap and water basin or disposable cloth', 'otherNumAtRisk': 2525, 'otherNumAffected': 26, 'seriousNumAtRisk': 2525, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2422, 'numEvents': 43, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 2525, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2422', 'groupId': 'OG000'}, {'value': '2525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Daily bathing with 2% chlorhexidine gluconate\n\n2% Chlorhexidine gluconate cloth: Daily bathing'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Standard bathing with soap and water basin or disposable cloth'}], 'classes': [{'categories': [{'measurements': [{'value': '3.52', 'groupId': 'OG000', 'lowerLimit': '2.64', 'upperLimit': '4.61'}, {'value': '4.93', 'groupId': 'OG001', 'lowerLimit': '3.91', 'upperLimit': '6.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were followed for the duration of ICU stay, median stay 3 days', 'description': 'incidence of bacteremia comparing those in treatment and control groups', 'unitOfMeasure': 'events per 1000 at-risk days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population'}, {'type': 'SECONDARY', 'title': 'Central Line Associated-bloodstream Infection (CLABSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2422', 'groupId': 'OG000'}, {'value': '2525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Daily bathing with 2% chlorhexidine gluconate\n\n2% Chlorhexidine gluconate cloth: Daily bathing'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Standard bathing with soap and water basin or disposable cloth'}], 'classes': [{'categories': [{'measurements': [{'value': '1.63', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '2.79'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.33'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'participants were followed for the duration of ICU stay, median stay 3 days', 'description': 'Comparing incidence of central line-associated bloodstream infections between treatment and control groups', 'unitOfMeasure': 'events per 1000 at-risk days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Bacteremia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1547', 'groupId': 'OG000'}, {'value': '2525', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'Daily bathing with 2% chlorhexidine gluconate'}, {'id': 'OG001', 'title': 'Control', 'description': 'Standard bathing with soap and water basin or disposable cloth'}], 'classes': [{'categories': [{'measurements': [{'value': '3.28', 'groupId': 'OG000', 'lowerLimit': '2.277', 'upperLimit': '4.58'}, {'value': '4.93', 'groupId': 'OG001', 'lowerLimit': '3.91', 'upperLimit': '6.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'duration of ICU stay, median 3 days', 'description': 'per protocol analysis of incidence of bacteremia comparing those in treatment and control groups', 'unitOfMeasure': 'events per 1000 at-risk days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes per protocol population of 1547 of 2422 in the treatment arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '2% Chlorhexidine Gluconate Cloth', 'description': 'Daily bathing with 2% chlorhexidine gluconate\n\n2% Chlorhexidine gluconate cloth: Daily bathing'}, {'id': 'FG001', 'title': 'Standard Bath', 'description': 'Standard bathing with soap and water basin or disposable cloth'}], 'periods': [{'title': 'Period 1 (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'intention to treat (ITT)', 'groupId': 'FG000', 'numSubjects': '1319'}, {'comment': 'ITT', 'groupId': 'FG001', 'numSubjects': '1199'}]}, {'type': 'Per Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '880'}, {'groupId': 'FG001', 'numSubjects': '1199'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1319'}, {'groupId': 'FG001', 'numSubjects': '1199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2 Washout (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 3 (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'number not equal to period 1 due to unit cross over design', 'groupId': 'FG000', 'numSubjects': '1103'}, {'comment': 'number not equal to period 1 due to unit cross over design', 'groupId': 'FG001', 'numSubjects': '1326'}]}, {'type': 'Per Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '667'}, {'groupId': 'FG001', 'numSubjects': '1326'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1103'}, {'groupId': 'FG001', 'numSubjects': '1326'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The hospital ICU units underwent a crossover study design, so the ICUs recruited participants in the assigned treatment or control group, then the unit had a washout period, then the unit switched to the alternative assignment of intervention or control for a separate population of participants that were admitted into the ICU.', 'preAssignmentDetails': '5659 enrolled visits in the study, but 712 were excluded from analysis as they did not meet the eligibility criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2422', 'groupId': 'BG000'}, {'value': '2525', 'groupId': 'BG001'}, {'value': '4947', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Daily bathing with 2% chlorhexidine gluconate\n\n2% Chlorhexidine gluconate cloth: Daily bathing'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Standard bathing with soap and water basin or disposable cloth'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'BG000', 'lowerLimit': '1.1', 'upperLimit': '12.9'}, {'value': '4.8', 'groupId': 'BG001', 'lowerLimit': '1.1', 'upperLimit': '12.7'}, {'value': '4.8', 'groupId': 'BG002', 'lowerLimit': '1.1', 'upperLimit': '12.9'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '1389', 'groupId': 'BG000'}, {'value': '1388', 'groupId': 'BG001'}, {'value': '2777', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '1033', 'groupId': 'BG000'}, {'value': '1137', 'groupId': 'BG001'}, {'value': '2170', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '1271', 'groupId': 'BG000'}, {'value': '1269', 'groupId': 'BG001'}, {'value': '2540', 'groupId': 'BG002'}]}]}, {'title': 'non-Caucasian', 'categories': [{'measurements': [{'value': '1151', 'groupId': 'BG000'}, {'value': '1256', 'groupId': 'BG001'}, {'value': '2407', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'PRISM III Score', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '13'}, {'value': '5', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '5', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': 'Severity score that predicts mortality. Range 0 (lowest mortality risk) to 74 (highest mortality risk)', 'unitOfMeasure': 'score', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5659}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-19', 'studyFirstSubmitDate': '2007-10-24', 'resultsFirstSubmitDate': '2015-03-31', 'studyFirstSubmitQcDate': '2007-10-24', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-09-01', 'studyFirstPostDateStruct': {'date': '2007-10-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bacteremia', 'timeFrame': 'duration of ICU stay, median 3 days', 'description': 'per protocol analysis of incidence of bacteremia comparing those in treatment and control groups'}], 'primaryOutcomes': [{'measure': 'Bacteremia', 'timeFrame': 'participants were followed for the duration of ICU stay, median stay 3 days', 'description': 'incidence of bacteremia comparing those in treatment and control groups'}], 'secondaryOutcomes': [{'measure': 'Central Line Associated-bloodstream Infection (CLABSI)', 'timeFrame': 'participants were followed for the duration of ICU stay, median stay 3 days', 'description': 'Comparing incidence of central line-associated bloodstream infections between treatment and control groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intensive care unit', 'Healthcare associated infections (HAI)', 'pediatric'], 'conditions': ['Nosocomial Infections']}, 'referencesModule': {'references': [{'pmid': '23363666', 'type': 'RESULT', 'citation': 'Milstone AM, Elward A, Song X, Zerr DM, Orscheln R, Speck K, Obeng D, Reich NG, Coffin SE, Perl TM; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013 Mar 30;381(9872):1099-106. doi: 10.1016/S0140-6736(12)61687-0. Epub 2013 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The investigators propose to conduct a large clinical study to determine if daily bathing with chlorhexidine impregnated cloths will reduce the incidence of healthcare-associated infections in the Pediatric Intensive Care Unit (PICU).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '2 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in pediatric intensive care unit\n\nExclusion Criteria:\n\n* Patients with a history of an allergic reaction to chlorhexidine\n* Patients less than 2 months of age\n* Patients with severe skin disease or burn\n* Patients with an indwelling epidural catheter or lumbar drain'}, 'identificationModule': {'nctId': 'NCT00549393', 'briefTitle': 'Study of Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Impact of Daily Bathing With Chlorhexidine Impregnated Cloths on Nosocomial Infections in the Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': 'NA_00006799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Daily bathing with 2% chlorhexidine gluconate', 'interventionNames': ['Drug: 2% Chlorhexidine gluconate cloth']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Standard bathing with soap and water basin or disposable cloth'}], 'interventions': [{'name': '2% Chlorhexidine gluconate cloth', 'type': 'DRUG', 'description': 'Daily bathing', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': "Children's National Medical Center", 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Louis Children's Hospital", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Trish M Perl, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}, {'name': 'Aaron Milstone, MD MHS', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sage Products, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}