Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT05485051
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Daily Chlorexidine Bath for Health Care Associated Infection Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003428', 'term': 'Cross Infection'}, {'id': 'D053717', 'term': 'Pneumonia, Ventilator-Associated'}], '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'}, {'id': 'D000077299', 'term': 'Healthcare-Associated Pneumonia'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013501', 'term': 'Surface-Active Agents'}, {'id': 'D012915', 'term': 'Soaps'}], 'ancestors': [{'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003902', 'term': 'Detergents'}, {'id': 'D006795', 'term': 'Household Products'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The study consists in two intervention (chlorhexidine baths) periods (three months each period) and two control (usual baths) periods (three months each period) for each cluster. The clusters will crossover between intervention and control with one month of washout period between different periods.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15730}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of healthcare-associated infections (HAI)', 'timeFrame': 'Within each cluster duration (90 days)', 'description': 'Composite outcome of the following HAI:\n\nVentilator associated pneumonia (VAP) Central line-associated blood stream infections (CLABSI) Catheter-associated urinary tract infection (CAUTI)'}], 'secondaryOutcomes': [{'measure': 'Rates of multi-drug-resistant pathogens', 'timeFrame': 'Within each cluster duration (90 days)', 'description': 'Rates of positive clinical microbiological cultures (colonization and infection) by multi-drug-resistant (MDR) pathogens.'}, {'measure': 'Ventilator associated pneumonia (VAP)', 'timeFrame': 'Within each cluster duration (90 days)', 'description': 'Rates of Ventilator associated pneumonia (VAP)'}, {'measure': 'Central line-associated blood stream infections (CLABSI)', 'timeFrame': 'Within each cluster duration (90 days)', 'description': 'Rates of Central line-associated blood stream infections (CLABSI)'}, {'measure': 'Catheter-associated urinary tract infection (CAUTI)', 'timeFrame': 'Within each cluster duration (90 days)', 'description': 'Rates of Catheter-associated urinary tract infection (CAUTI)'}, {'measure': 'Hospital length of stay', 'timeFrame': 'Until hospital discharge, maximum 90 days', 'description': 'Hospital length of stay'}, {'measure': 'Intensive Care Unit length of stay', 'timeFrame': 'Until Intensive Care Unit discharge, maximum 90 days', 'description': 'Intensive Care Unit length of stay'}, {'measure': 'Antibiotic use', 'timeFrame': 'Within each cluster duration (90 days)', 'description': 'Antibiotic use per unit'}, {'measure': 'In hospital mortality', 'timeFrame': 'Maximum 90 days after randomization', 'description': 'In hospital mortality'}, {'measure': 'Intensive Care Unit mortality', 'timeFrame': 'Maximum 90 days after randomization', 'description': 'Intensive Care Unit mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Health Care Associated Infection', 'Ventilator Associated Pneumonia', 'Central Line-associated Bloodstream Infection (CLABSI)', 'Catheter-Associated Urinary Tract Infection']}, 'descriptionModule': {'briefSummary': 'Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.', 'detailedDescription': 'Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* All patients ≥ 18 years/old admitted to the participants's ICUs\n\nExclusion Criteria:\n\n* History of chlorhexidine allergy"}, 'identificationModule': {'nctId': 'NCT05485051', 'acronym': 'CLEAN-IT', 'briefTitle': 'Daily Chlorexidine Bath for Health Care Associated Infection Prevention', 'organization': {'class': 'OTHER', 'fullName': 'Hospital do Coracao'}, 'officialTitle': 'Impact of Chlorhexidine Bath on Healthcare-associated Infections Acquisitions in Intensive Care Units - A Cluster Randomized Trial', 'orgStudyIdInfo': {'id': 'ip_hcor_cleanit'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine baths', 'description': 'All patients in the cluster randomized to the intervention arm will receive baths using a 2% chlorhexidine digluconate solution with surface-active agents during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.', 'interventionNames': ['Other: 2% chlorhexidine digluconate solution with surface-active agents']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Usual baths', 'description': 'All patients in the cluster randomized to the intervention arm will receive baths using soap and water according to the current practice in each center during the intervention period. All other infection control and cleaning procedures will be performed according to the current practice in each center.', 'interventionNames': ['Other: Usual Baths']}], 'interventions': [{'name': '2% chlorhexidine digluconate solution with surface-active agents', 'type': 'OTHER', 'otherNames': ['Chlorhexidine baths'], 'description': 'Bathing will be performed at least daily using 2% chlorhexidine digluconate solution with surface-active agents on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.', 'armGroupLabels': ['Chlorhexidine baths']}, {'name': 'Usual Baths', 'type': 'OTHER', 'otherNames': ['Soap and water baths'], 'description': 'Bathing will be performed at least daily using soap and water (performed according to the current practice in each center) on all applicable bathing surfaces, which consists of the entire body surface of the patient except eyes, inner ear, oral mucosa, and areas of loss of skin continuity (such as burnt areas, pressure injuries, etc.); These areas will be bathed according to each center current practice.', 'armGroupLabels': ['Usual baths']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Colatina', 'state': 'Espírito Santo', 'country': 'Brazil', 'facility': 'Hospital Maternidade São José - UNESC - Fundação Social Rural de Colatina', 'geoPoint': {'lat': -19.53944, 'lon': -40.63056}}, {'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital da Bahia', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'facility': 'Hospital da Cidade', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Hospital Universitário de Brasília', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'city': 'Maringá', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Hospital Municipal de Maringá', 'geoPoint': {'lat': -23.42528, 'lon': -51.93861}}, {'city': 'Santarém', 'state': 'Pará', 'country': 'Brazil', 'facility': 'Hospital Regional do Baixo Amazonas Dr. Waldemar Penna', 'geoPoint': {'lat': -2.44306, 'lon': -54.70833}}, {'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Universidade Federal de Pernambuco', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}, {'city': 'Caxias do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Geral de Caxias do Sul', 'geoPoint': {'lat': -29.16806, 'lon': -51.17944}}, {'city': 'Santa Cruz do Sul', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital Santa Cruz', 'geoPoint': {'lat': -29.7175, 'lon': -52.42583}}, {'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Hospital Nereu Ramos', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'Florianópolis', 'state': 'Santa Catarina', 'country': 'Brazil', 'facility': 'Instituto Baía Sul de Ensino e Pesquisa Irineu May Brodbeck', 'geoPoint': {'lat': -27.59667, 'lon': -48.54917}}, {'city': 'Aracaju', 'state': 'Sergipe', 'country': 'Brazil', 'facility': 'Hospital São Lucas', 'geoPoint': {'lat': -10.91111, 'lon': -37.07167}}, {'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Aviccena', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Naval Marcílio Dias', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'AC Camargo Câncer Center', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'BP-A Beneficiência Portuguesa de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Bruno M Tomazini, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'btomazini@hcor.com.br'}, {'name': 'Alexandre B Cavalcanti, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'HCor Research Institute Director'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': '1 year after publication of primary results', 'ipdSharing': 'YES', 'accessCriteria': 'Submission of a statistical analysis plan for the purposed analyses. Compliance with Brazilian. Data privacy law.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital do Coracao', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Sírio-Libanês', 'class': 'UNKNOWN'}, {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, {'name': 'Hospital Moinhos de Vento', 'class': 'OTHER'}, {'name': 'Hospital Alemão Oswaldo Cruz', 'class': 'OTHER'}, {'name': 'A Beneficência Portuguesa de São Paulo', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}