Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:54 PM
Study NCT ID:
NCT06456151
Status:
RECRUITING
Last Update Posted:
2025-06-05
First Post:
2024-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Invasive Candidiasis in Critical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058365', 'term': 'Candidiasis, Invasive'}], 'ancestors': [{'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Left-over blood samples from patients will be used in the study. The study subjects will be also asked for a sample of urine.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-02', 'studyFirstSubmitDate': '2024-06-04', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute-phase biomarkers dynamics - procalcitonin', 'timeFrame': '8 days', 'description': "The levels of procalcitonin will be observed in time and measured in μg/L. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'Acute-phase biomarkers dynamics - interleukin-6', 'timeFrame': '8 days', 'description': "The levels of interleukin-6 will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'Acute-phase biomarkers dynamics - interleukin-10', 'timeFrame': '8 days', 'description': "The levels of interleukin-10 will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'Acute-phase biomarkers dynamics - Presepsin', 'timeFrame': '8 days', 'description': "The levels of Presepsin will be observed in time and measured in pg/ml. The follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'Acute-phase biomarkers dynamics - C-reactive protein', 'timeFrame': '8 days', 'description': "The levels of C-reactive protein will be observed in time and measured in mg/dL.\n\nThe follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'Acute-phase biomarkers dynamics - 1,3-β-D-glucan', 'timeFrame': '8 days', 'description': "The levels of C-reactive protein will be observed in time and measured in pg/ml.\n\nThe follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'Acute-phase biomarkers dynamics - pentraxin 3', 'timeFrame': '8 days', 'description': "The levels of C-reactive protein will be observed in time and measured in ng/ml.\n\nThe follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}, {'measure': 'T2Candida test', 'timeFrame': 'One-time measurement at the enrolment into the study', 'description': 'The T2Candida test is able to detect the presence of Candida albicans, C. tropicalis, C. glabrata, C. krusei and C. parapsilosis. The results will be assessed as positive or negative.'}, {'measure': 'Lipopolysaccharide binding protein', 'timeFrame': 'One-time measurement at the enrolment into the study', 'description': "The levels of Lipopolysaccharide binding protein (LBP)\\_S/P will be observed in time and measured in mg/L.\n\nThe follow-up will last 8 days, the patient may be observed repeatedly, depend-ing on the patient's condition."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['invasive candidiasis', 'biomarkers', 'candida sepsis'], 'conditions': ['Invasive Candidiasis']}, 'referencesModule': {'references': [{'pmid': '35330311', 'type': 'BACKGROUND', 'citation': 'Dobias R, Kanova M, Petejova N, Pisti SK, Bocek R, Krejci E, Struzkova H, Cachova M, Tomaskova H, Hamal P, Havlicek V, Raska M. Combined Use of Presepsin and (1,3)-beta-D-glucan as Biomarkers for Diagnosing Candida Sepsis and Monitoring the Effectiveness of Treatment in Critically Ill Patients. J Fungi (Basel). 2022 Mar 17;8(3):308. doi: 10.3390/jof8030308.'}, {'pmid': '31585478', 'type': 'BACKGROUND', 'citation': 'Bassetti M, Giacobbe DR, Vena A, Wolff M. Diagnosis and Treatment of Candidemia in the Intensive Care Unit. Semin Respir Crit Care Med. 2019 Aug;40(4):524-539. doi: 10.1055/s-0039-1693704. Epub 2019 Oct 4.'}], 'seeAlsoLinks': [{'url': 'https://www.who.int/publications/i/item/9789240060241', 'label': 'World Health Organisation (WHO) fungal priority pathogens list to guide research, development and public health action'}]}, 'descriptionModule': {'briefSummary': 'The combination of acute phase marker monitoring and the "T2Candida" assay (name of the test) will represent an acceleration of the identification of the causative agent of mycotic infection, a significant improvement in the specificity and positive predictive value of this strategy in the diagnosis of invasive candidiasis and candidemia in ICU patients, thereby improving the clinical condition of patients and reducing the cost of specific antifungal therapy.', 'detailedDescription': 'Speed of response in the treatment of sepsis is crucial for the patient. The time from the collection of a positive haemoculture to the identification of the causative agent of sepsis is around 2 days; therefore, physicians in intensive care units deploy combined empiric antibiotic and antifungal therapy immediately when acute phase markers such as procalcitonin, interleukin-6, Presepsin, C-reactive protein are elevated. A new acute phase marker is lipopolysaccharide-binding protein, which, together with Presepsin, appears to be a suitable marker to distinguish invasive candida infections from bacterial infections. But its kinetics needs to be further analyzed.\n\nAt the same time, the causative agent of sepsis, G-/G+ bacteria or yeast, must be identified as soon as possible. Haemoculture and culture of the established drain is the gold standard, but the disadvantage is the low sensitivity and the time delay to obtain the result. It is therefore advisable to combine haemoculture with molecular biology-based tests that can identify the causative organism within hours. Conversely, the disadvantage of these tests is that they identify only the most common sepsis pathogens and do not determine susceptibility to antibiotics and antifungals, but the advantage is that with prophylaxis in place, these tests are often positive when haemoculture is negative. The T2Candida test can detect Candida albicans, Candida tropicalis, Candida glabrata, Candida krusei and Candida parapsilosis, which are the more common causative agents of mycotic bloodstream infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with suspected invasive candidasis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patients\n* new onset sepsis\n* rise in body temperature \\>38°C according to The Third Consensus Definitions for Sepsis and Septic Shock\n* colonization with Candida spp. from more than 1 non-sterile site\n* body temperature \\>38 °C despite 5 days of broad-spectrum antibiotic therapy with the presence of at least 1 of the following risk factors: abdominal surgery, secondary peritonitis, pancreatitis, central venous catheter (CVC) insertion, total parenteral nutrition (CPV), dialysis, steroid therapy, immunosuppressive therapy, or liver transplantation\n* microbiological test results will be reviewed and categorized based on whether Candida sp. is isolated from at least 2 non-sterile sites (±3 days) and whether there is an alternative microbiological diagnosis.\n\nExclusion Criteria:\n\n* not signing the informed consent with participation in the study\n* administration of antifungal therapy prior to collection of the biological material required for the study'}, 'identificationModule': {'nctId': 'NCT06456151', 'briefTitle': 'Invasive Candidiasis in Critical Care', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Invasive Candidiasis in Critical Care', 'orgStudyIdInfo': {'id': 'ULM-01-Invasive candidiasis'}, 'secondaryIdInfos': [{'id': '03/RVO-FNOs/2024', 'type': 'OTHER_GRANT', 'domain': 'University Hospital Ostrava'}, {'id': 'SGS06/LF/2024', 'type': 'OTHER_GRANT', 'domain': 'Faculty of Medicine, University of Ostrava'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with suspected invasive candidiasis', 'description': 'Patients with suspected invasive candidiasis will be enrolled in this study arm.', 'interventionNames': ['Diagnostic Test: Invasive candidiasis test', 'Other: Urine sample collection for future research']}], 'interventions': [{'name': 'Invasive candidiasis test', 'type': 'DIAGNOSTIC_TEST', 'description': 'The combination of acute phase marker monitoring and the T2Candida assay will be assessed.', 'armGroupLabels': ['Patients with suspected invasive candidiasis']}, {'name': 'Urine sample collection for future research', 'type': 'OTHER', 'description': 'Patients will be asked to provide a urine sample for future research (urine biobank).', 'armGroupLabels': ['Patients with suspected invasive candidiasis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '708 52', 'city': 'Ostrava', 'state': 'Moravian-Silesian Region', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}, {'name': 'Hana Slepčanová, Mgr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marcela Káňová, Assoc.Prof.,MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Tomáš Zaoral, MD,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Radim Dobiáš, Mgr.,PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Iveta Láryšová', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '150 06', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Vanda Chrenková, MD', 'role': 'CONTACT', 'email': 'vanda.chrenkova@fnmotol.cz', 'phone': '0042022443', 'phoneExt': '5390'}, {'name': 'Vanda Chrenková, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Motol', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Jiří Hynčica', 'role': 'CONTACT', 'email': 'jiri.hyncica@fno.cz', 'phone': '0042059737', 'phoneExt': '2587'}], 'overallOfficials': [{'name': 'Hana Slepčanová, Mgr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data available to other researchers. The data may be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Motol', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}