Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 7:17 AM
Study NCT ID:
NCT05576233
Status:
UNKNOWN
Last Update Posted:
2023-02-01
First Post:
2022-10-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
• Comparison of Blood Culture Contamination Rates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-31', 'studyFirstSubmitDate': '2022-10-09', 'studyFirstSubmitQcDate': '2022-10-09', 'lastUpdatePostDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Contamination', 'timeFrame': '14 days', 'description': 'The primary endpoint of the study was to reduce the rate of contamination in blood cultures.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood culture contamination', 'Chloraprep ( alcohol/ chlorhexidine)', 'Povidine/iodine', 'Topical disinfectants'], 'conditions': ['Blood Culture Contamination']}, 'descriptionModule': {'briefSummary': 'In this study, blood culture contamination rates will be compared in patients who used povidine/iodine-alcohol and chlorhexidine/alcohol, which were applied before the blood culture was taken by randomized two methods routinely used in this study.', 'detailedDescription': 'Detection of the pathogen in blood cultures as soon as possible reduces mortality significantly by providing timely initiation of treatment1. However, when skin antisepsis is not performed properly, an increase in the rate of contamination is observed. In this study, it was planned to compare the contamination rate of two antiseptics, povidine iodine/alcohol and Chlorhexidine/alcohol used as skin antisepsis, in the blood culture taken.\n\nFull randomization" will be applied in the study. Multiples of 3 of the patients to be included in the study will be included in the "Chloraprep" group, the remaining patients and multiples of 2 will be included in the "povidine/iodine" group. . According to the number of samples determined for each institution, patients who came to the outpatient clinic during data collection and accepted to participate in the study will be randomly selected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients who will be hospitalized at SBU Izmir Dr. Patients who are hospitalized in the Pediatric Infection Service of Behçet Uz Pediatrics and Surgery Training and Research Hospital, and who will require blood culture indications will participate in the study If they are willing to\n\nExclusion Criteria:\n\n* The patents with central lines will be excluded.\n* The patient who were transferred from ICU's will be excluded."}, 'identificationModule': {'nctId': 'NCT05576233', 'briefTitle': '• Comparison of Blood Culture Contamination Rates', 'organization': {'class': 'OTHER', 'fullName': "Dr. Behcet Uz Children's Hospital"}, 'officialTitle': 'Comparison of Blood Culture Contamination Rates Between the Use of Povidine Iodine/Alcohol for Skin Antisepsis and the Use of Chlorhexidine/Alcohol (ChloraPrep) for Skin Antisepsis: An Open-label, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'skin antisepsis study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1.The culture taken after disinfection with providing/iodine', 'description': '1.Blood cultures routinely performed with alcohol/povidine-iodine', 'interventionNames': ['Procedure: disinfection of the surface that the blood culture is taken']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2.The culture taken after disinfection with chlorhexidine/alcohol', 'description': '2\\. Blood cultures routinely performed with chlorhexidine/alcohol', 'interventionNames': ['Procedure: disinfection of the surface that the blood culture is taken']}], 'interventions': [{'name': 'disinfection of the surface that the blood culture is taken', 'type': 'PROCEDURE', 'description': 'lood cultures can be routinely performed with alcohol/povidine-iodine or alcohol/chlorhexidine. The topical disinfectants used in the two applications are the topical disinfectants included in the guidelines and currently applied in our hospital.', 'armGroupLabels': ['1.The culture taken after disinfection with providing/iodine', '2.The culture taken after disinfection with chlorhexidine/alcohol']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Dr. Behcet Uz Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor. Dr.', 'investigatorFullName': 'ilker devrim', 'investigatorAffiliation': "Dr. Behcet Uz Children's Hospital"}}}}