Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT06069505
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '80 ml of blood will be stored to analyze DNA extraction for PCR on serum and on plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2023-10-02', 'studyFirstSubmitQcDate': '2023-10-02', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Performance of two different PCR test', 'timeFrame': '1 week', 'description': "The sensitivity and specificity will be determined of the different PCR's tested including the commercially available AsperGenius (Pathonostics, Maastricht) and the in-house PCR. For this purpose a patients diagnosed with proven or probable IPA according to the EORTC/MSG definition will be used as the gold standard."}, {'measure': 'Performance of two different media for the PCR test', 'timeFrame': '1 week', 'description': 'Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined'}, {'measure': 'Determination of best PCR cycle threshold', 'timeFrame': '1 week', 'description': 'Extraction medium (serum versus plasma) and extraction volume (1, 3 or 10 ml) that results in best sensitivity and specificity will be determined'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['invasive aspergillosis', 'PCR'], 'conditions': ['Invasive Aspergillosis']}, 'descriptionModule': {'briefSummary': "Invasive aspergillosis (IA) is the most common mould infection in immunocompromised patients with haematological disease. Voriconazole, a triazole, improves overall survival of patients with an IA and is the mainstay of therapy. Resistance of A. Fumigatus emerged as an important clinical problem and infections with azole resistant Aspergillus have a high mortality. Nowhere in the world, azole resistance is more prevalent than in the Netherlands. Rapid detection of resistance is key to improve the patient's outcome but fungal cultures take time and are often negative. The investigators aim to detect azole resistance associated mutations in fungal DNA extracted directly from serum or plasma to accelerate diagnosis and improve outcome of patients infected with azole resistant A. fumigatus."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '100 haematology patients with a radiologically suspected invasive pulmonary aspergillosis and undergoing a bronchoalveolar lavage. After the BAL diagnostic tests have become available, confirmation of the suspected infection is expected in 25 patients and therefore 25 evaluable patients will remain. The investigators decided that another 50 patients should be included because only 25% had an invasive fungal infection after interim analysis of the first 50 patients included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older.\n* Lung CT shows lesions that fulfil the EORTC/MSG radiological criteria of possible invasive fungal infection.\n* A bronchoalveolar lavage is planned or has been performed \\<48hrs earlier\n\nExclusion Criteria:\n\n\\- Patients unable or unwilling to provide consent'}, 'identificationModule': {'nctId': 'NCT06069505', 'acronym': 'ARPO', 'briefTitle': 'Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Detection of Azole Resistance Inducing Mutations on DNA Extracted Directly From Serum or Plasma of Immunocompromised Patients With an Invasive Aspergillus Infection Azole Resistance PCR Optimalization-study', 'orgStudyIdInfo': {'id': 'NL62004.078.17'}, 'secondaryIdInfos': [{'id': 'MEC-2017-391', 'type': 'OTHER', 'domain': 'METC Erasmus Medical Center'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Aspergillus PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'Aspergillus PCR will be performed on different volumes of serum and plasma of patients with hematological malignancies with suspicion for invasive fungal infection.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000 CA', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Bart J Rijnders, MD, PhD', 'role': 'CONTACT', 'email': 'b.rijnders@erasmusmc.nl', 'phone': '31107033510'}], 'facility': 'Erasmus Medical Center (EMC)', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Bart Rijnders, MD, PhD', 'role': 'CONTACT', 'email': 'b.rijnders@erasmusmc.nl', 'phone': '+31107033510'}, {'name': 'Hanne Lamberink, MD', 'role': 'CONTACT', 'email': 'h.lamberink@erasmusmc.nl'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bart Rijnders', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor in Infectious Diseases', 'investigatorFullName': 'Bart Rijnders', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}