Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-27 @ 3:01 PM
Study NCT ID:
NCT03364257
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2017-11-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood and plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion', 'timeFrame': '7 months', 'description': 'Sensitivity, specificity, negative predictive value, positive predictive value at inclusion'}], 'secondaryOutcomes': [{'measure': 'Antiobiotic use', 'timeFrame': '9 months', 'description': 'Type of antibiotic, duration of antibiotic course'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metagenomic', 'infection', 'diagnosis'], 'conditions': ['Febrile Neutropenia', 'Acute Leukemia', 'Stem Cell Transplantation', 'Infection']}, 'descriptionModule': {'briefSummary': 'Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia', 'detailedDescription': 'Febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with iDTECT Blood on Study Day 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with chemotherapy for Acute Leukaemia (AL) or Myelodysplastic Syndrome (MDS) or in the context of hematopoietic stem cell transplantation (HSCT), presenting a febrile neutropenic episode and suspected of infection', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age \\> 5 years and weight \\> 16 Kg\n2. Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed\n3. Patient presenting severe neutropenia (absolute neutrophil count \\< 0.5 Giga/L) anticipated to be long lasting (\\> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation\n4. Febrile episode (oral temperature \\> 38.3°C once, or 2 measures \\> 38.0°C taken 2h apart).\n\nExclusion Criteria:\n\n1. Known HIV infection or AIDS diagnosis\n2. Already microbiologically confirmed infection\n3. Patient status preventing the study test to be performed\n4. Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation"}, 'identificationModule': {'nctId': 'NCT03364257', 'acronym': 'IDENTIFY', 'briefTitle': 'iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pathoquest'}, 'officialTitle': 'National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection', 'orgStudyIdInfo': {'id': 'PTQ-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'iDTECT Blood', 'type': 'DIAGNOSTIC_TEST', 'description': 'Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Blanche, Prof, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Necker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Baruchel, Prof, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Souchet, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Salpétrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Petit, Prof, MD', 'role': 'CONTACT'}], 'facility': 'Hospital Trousseau', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Le Goff, MD', 'role': 'CONTACT'}, {'name': 'Socié, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thieblemont, Prof, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Raffoux, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hosptial Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Dangles', 'role': 'CONTACT', 'email': 'christine.dangles@pathoquest.com', 'phone': '+33687137695'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pathoquest', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}