Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 1:28 AM
Study NCT ID:
NCT04904666
Status:
COMPLETED
Last Update Posted:
2021-05-27
First Post:
2021-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2021-02-22', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of Bleach baths as determined by the incidence of adverse or serious adverse events', 'timeFrame': 'November 26, 2019 - October 25, 2020'}], 'secondaryOutcomes': [{'measure': 'Identification of bacterial colonization from pathogens belonging to the ESKAPE group', 'timeFrame': 'November 26, 2019 - October 25, 2020', 'description': 'Identification of colonization by Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter species'}, {'measure': 'Percentage of patients remaining colonized 3, 5 and 7 days after daily baths', 'timeFrame': 'November 26, 2019 - October 25, 2020'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Safety Issues']}, 'descriptionModule': {'briefSummary': 'Non critical hospitalized patients were bathed daily with 4 substances: bleach at .005%, bleach at .0125%, clorhexidine 2% and soap and water.\n\n76 patients were enrolled and divided 19 subjects per group. Each patient was cultured with swab technique in palm, antecubital fold and armpit at day 0, day 3 and day 7 of enrollment.\n\nBacterial cultures were incubated and compared if decolonization occurred. Adverse events were evaluated in all patients.\n\nOnly 1 patient had and adverse event and was dry skin. Before patient was enrolled, he had dry skin because of his baseline disease. Moisturizing lotion was applied and patient continue in the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non critical hospitalized patients in internal medicine that met inclusion criteria. Subjects should be hospitalized por 1 week.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non critical hospitalized patients in internal medicine\n* 18 years old and older\n\nExclusion Criteria:\n\n* Burn patients\n* Pregnant women\n* Chloride hypersensitivity'}, 'identificationModule': {'nctId': 'NCT04904666', 'briefTitle': 'Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Dr. Jose E. Gonzalez'}, 'officialTitle': 'Safety and Efficacy of Bleach Baths in Non Critical Hospitalized Patients', 'orgStudyIdInfo': {'id': 'IF19-00010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Bleach baths with .0125%'}, {'label': 'Clorhexidine 2%'}, {'label': 'Soap and water'}, {'label': 'Bleach baths with .005%'}]}, 'contactsLocationsModule': {'locations': [{'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'Hospital Universitario José E. Gonzalez', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Dr. Jose E. Gonzalez', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Infectious Diseases Department', 'investigatorFullName': 'Dr. Adrian Camacho-Ortiz', 'investigatorAffiliation': 'Hospital Universitario Dr. Jose E. Gonzalez'}}}}