Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-15 @ 6:13 PM
Study NCT ID:
NCT02734550
Status:
COMPLETED
Last Update Posted:
2022-08-19
First Post:
2016-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D016638', 'term': 'Critical Illness'}], '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'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'investigator-initiated prospective, multicenter, randomized, open, and parallel group study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 342}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-17', 'studyFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2022-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28 day mortality', 'timeFrame': '28 days'}], 'secondaryOutcomes': [{'measure': '28 day antifungal-free survival', 'timeFrame': '28 days'}, {'measure': 'Candida Colonization', 'timeFrame': '14 days', 'description': 'Candida colonization assessed by Candida Colonization Index'}, {'measure': 'Time to antifungal therapy', 'timeFrame': '14 days'}, {'measure': 'Duration of organ support', 'timeFrame': '14 days'}, {'measure': 'Mean total SOFA score', 'timeFrame': '14 days', 'description': 'Measure of organ dysfunction'}, {'measure': 'ICU and hospital length of stay', 'timeFrame': 'Hospital length of stay'}, {'measure': 'ICU and hospital mortality', 'timeFrame': 'Hospital length of stay'}, {'measure': 'Adverse events', 'timeFrame': '14 days'}, {'measure': 'Diagnostic performance of (1,3)-β-D-glucan in comparison to PCR and other experimental diagnostics', 'timeFrame': '2 days'}, {'measure': 'Pharmacoeconomics', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Sepsis', 'Invasive Candida Infection', 'Biomarker', '(1,3)-β-D-glucan', 'Antifungal therapy', 'Intensive care medicine', 'Critically ill'], 'conditions': ['Severe Sepsis', 'Septic Shock']}, 'referencesModule': {'references': [{'pmid': '30180873', 'type': 'BACKGROUND', 'citation': 'Bloos F, Held J, Schlattmann P, Brillinger N, Kurzai O, Cornely OA, Thomas-Ruddel D. (1,3)-beta-D-glucan-based diagnosis of invasive Candida infection versus culture-based diagnosis in patients with sepsis and with an increased risk of invasive Candida infection (CandiSep): study protocol for a randomized controlled trial. Trials. 2018 Sep 4;19(1):472. doi: 10.1186/s13063-018-2868-0.'}, {'pmid': '35708758', 'type': 'RESULT', 'citation': 'Bloos F, Held J, Kluge S, Simon P, Kogelmann K, de Heer G, Kuhn SO, Jarczak D, Motsch J, Hempel G, Weiler N, Weyland A, Druner M, Grundling M, Meybohm P, Richter D, Jaschinski U, Moerer O, Gunther U, Schadler D, Weiss R, Putensen C, Castellanos I, Kurzai O, Schlattmann P, Cornely OA, Bauer M, Thomas-Ruddel D; SepNet Study Group. (1 --> 3)-beta-D-Glucan-guided antifungal therapy in adults with sepsis: the CandiSep randomized clinical trial. Intensive Care Med. 2022 Jul;48(7):865-875. doi: 10.1007/s00134-022-06733-x. Epub 2022 Jun 16.'}]}, 'descriptionModule': {'briefSummary': 'This prospective randomized multicenter study evaluates whether the decision to prescribe antifungals guided by (1,3)-β-D-glucan in comparison to standard of care shortens time to antifungal therapy and reduces mortality in patients with severe sepsis or septic shock and a high risk of invasive candida infection.', 'detailedDescription': '(1,3)-β-D-glucan is a component of the cell wall of many fungi including candida spp. and is present in the blood of patients with invasive candida infection (ICI). Several studies showed a good diagnostic accuracy (1,3)-β-D-glucan in predicting ICI. However, others have challenged (1,3)-β-D-glucan as a diagnostic tool in critically ill patients as many substances used in the intensive care unit might affect the results of the assay. The goal of this study is to investigate whether (1,3)-β-D-glucan can early identify sepsis patients in need of antifungal therapy. Patients randomized to the standard of care group receive antifungals depending on microbiological results according to current guidelines. Patients randomized to the BDG group receive antifungals depending on the (1,3)-β-D-glucan plasma concentration on day 1 and day after diagnosing sepsis. Therapy may be modified according to microbiological results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sepsis or septic shock\n* Onset of sepsis no longer than 24 hours\n* Increased risk of invasive candida infection with at least one of the following criteria:\n\n * total parenteral nutrition ≥48 hours\n * abdominal surgery within the last 7 days\n * antimicrobial therapy for at least 48 hours within the last 7 days\n * Acute or chronic renal failure with renal replacement therapy\n* Age ≥18 years\n* Informed consent of the patient or legal representative or delayed consent process is started if patient is incapable of giving informed consent and no legal representative is available.\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Ongoing invasive candida infection\n* systemic antifungal therapy\n* liver cirrhosis Child C\n* cardiopulmonary bypass within the last 4 weeks\n* treatment with immunoglobulins within the last 14 days\n* immunosuppression (solid organ transplantation, AISA, leukopenia)\n* participation in another intervention study\n* no commitment to full therapy (i.e. DNR order)\n* Infauste Prognose aufgrund von Nebenerkrankungen\n* kin to or colleague of study personnel'}, 'identificationModule': {'nctId': 'NCT02734550', 'acronym': 'CandiSep', 'briefTitle': '(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection in Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Center for Sepsis Control and Care, Germany'}, 'officialTitle': '(1,3)-β-D-glucan Based Diagnosis of Invasive Candida Infection Versus Culture Based Diagnosis in Patients With Severe Sepsis or Septic Shock', 'orgStudyIdInfo': {'id': 'ZKSJ0087'}, 'secondaryIdInfos': [{'id': '01EO1502', 'type': 'OTHER_GRANT', 'domain': 'Federal Ministry of Education and Research of Germany'}, {'id': 'U1111-1181-8724', 'type': 'REGISTRY', 'domain': 'Universal Trial Number'}, {'id': 'DRKS00010285', 'type': 'REGISTRY', 'domain': 'German Clinical Trial Register'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Diagnosis of invasive candida infection according to standard of care.', 'interventionNames': ['Other: Standard of care']}, {'type': 'EXPERIMENTAL', 'label': '(1,3)-β-D-glucan guidance', 'description': 'Treatment according to BDG-result', 'interventionNames': ['Other: Standard of care', 'Other: (1,3)-β-D-glucan guided therapy']}], 'interventions': [{'name': 'Standard of care', 'type': 'OTHER', 'description': 'Patients are treated according to the ESCMID guidelines. Antifungal therapy is started if fungi are detected in the blood culture or other primary sterile body fluids.', 'armGroupLabels': ['(1,3)-β-D-glucan guidance', 'Control']}, {'name': '(1,3)-β-D-glucan guided therapy', 'type': 'OTHER', 'description': 'Serum for (1,3)-β-D-glucan measurement is obtained after enrollment and 24 hours later. Antifungal therapy is started if at least one sample is 80 pg/ml or higher. If concomitantly taken microbiological cultures remain negative, antifungal therapy is continued only, if both (1,3)-β-D-glucan were at least 80 pg/ml. Blood cultures or other samples from primary sterile body fluids positive for fungi are treated with antifungals irrespective the (1,3)-β-D-glucan results.', 'armGroupLabels': ['(1,3)-β-D-glucan guidance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Hospital Augsburg', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'city': 'Bad Saarow', 'country': 'Germany', 'facility': 'HELIOS Klinikum Bad Saarow', 'geoPoint': {'lat': 52.28333, 'lon': 14.06667}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'University Hospital Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '26721', 'city': 'Emden', 'country': 'Germany', 'facility': 'Hospital Emden', 'geoPoint': {'lat': 53.36592, 'lon': 7.20846}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University Hospital Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '37099', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'University Hospital Göttingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '17475', 'city': 'Greifswald', 'country': 'Germany', 'facility': 'University Hospital Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}, {'city': 'Halle', 'country': 'Germany', 'facility': 'University Hospital Halle', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'University Hospital Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University Hospital Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '07740', 'city': 'Jena', 'country': 'Germany', 'facility': 'Jena University Hospital', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'zip': '24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'University Hospital Schleswig-Holstein', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '04103', 'city': 'Leipzig', 'country': 'Germany', 'facility': 'University Hospital Leipzig', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}, {'city': 'Münster', 'country': 'Germany', 'facility': 'University Hospital Münster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '26133', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Hospital Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'city': 'Siegen', 'country': 'Germany', 'facility': 'Diakonie Klinikum', 'geoPoint': {'lat': 50.87481, 'lon': 8.02431}}, {'city': 'Würzburg', 'country': 'Germany', 'facility': 'University Hospital Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Frank Bloos, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jena University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Sepsis Control and Care, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Center for Clinical Studies, University Hospital Jena, Germany', 'class': 'UNKNOWN'}, {'name': 'Dept. of Microbiology, University Hospital Erlangen, Germany', 'class': 'UNKNOWN'}, {'name': 'Institute of Medical Statistics, Computer Sciences and Documentation, University Hospital Jena, Germany', 'class': 'UNKNOWN'}, {'name': 'Federal Ministry of Education and Research, Berlin, Germany', 'class': 'UNKNOWN'}, {'name': 'Associates of Cape Cod, Inc., East Falmouth, MA, USA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}