Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-03 @ 1:15 AM
Study NCT ID:
NCT06929494
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-16
First Post:
2025-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Candidemia in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2025-04-08', 'lastUpdatePostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of risk factors for candidemia', 'timeFrame': 'Throughout ICU stay (from admission to 28 days post ICU discharge)', 'description': 'Identification of risk factors for candidemia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Candidal sepsis (candidemia) is a criticals problem in patients hospitalized in the intensive care unit, with a significant impact on morbidity and mortality. Risk factors for candidemia in intensive care patients included age, presence of a central venous catheter, inpatient surgery, and administration of parenteral nutrition (TPN). Mortality in patients with candidemia is estimated at 50-60%. Early identification and treatment, including control of the source of infection, are essential to improve morbidity and mortality in these patients.\n\nIn this study, we would like to identify risk factors for the development of candidemia in intensive care patients, including those who have not undergone abdominal surgery, and to examine what percentage of patients who developed candidemia were given empirical antifungal therapy and what factors influenced the decision to give or not to give such empirical therapy.\n\nStudy design: A retrospective study based on data collection from computerized systems will include patients who were hospitalized in the intensive care unit from January 2014 to December 2024 and were diagnosed with Candida in at least one blood culture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the ICU from January 2014 to December 2024 and had at least one positive blood culture for candidemia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Patients admitted to the ICU from January 2014 to December 2024 and had at least one positive blood culture for candidemia -\n\nExclusion Criteria: Missing data\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06929494', 'briefTitle': 'Candidemia in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Candidemia in Critically Ill Patients: Risk Factors and Predictive Factors', 'orgStudyIdInfo': {'id': 'MMC-0086-25'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Identification of risk factors for candidemia', 'type': 'OTHER', 'description': 'Identification of risk factors for candidemia'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'sara dichtwald', 'investigatorAffiliation': 'Meir Medical Center'}}}}