Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-04-17 @ 7:10 AM
Study NCT ID:
NCT01819792
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2013-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 119}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2013-03-18', 'studyFirstSubmitQcDate': '2013-03-25', 'lastUpdatePostDateStruct': {'date': '2018-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs', 'timeFrame': 'at day 15', 'description': 'Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.'}], 'secondaryOutcomes': [{'measure': 'seasonal viral infection incidence measure', 'timeFrame': '18 months after inclusion'}, {'measure': 'risk factor of viral infections research', 'timeFrame': '18 months after inclusion'}, {'measure': 'viral infections related morbidity and mortality estimation', 'timeFrame': '18 months after inclusion'}, {'measure': 'bacterial and fungal co-infection estimation', 'timeFrame': '18 months after inclusion'}, {'measure': 'description of antiviral therapeutic used for treating patients', 'timeFrame': '18 months after inclusion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Acute Myeloid Leukemia'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'Infectious morbidity and mortality is a major complication of AML (Acute Myeloid Leukemia) induction and consolidation chemotherapies related aplasia. The main aim of this study is to measure incidence of respiratory viral infections during AML induction and consolidation chemotherapy related aplasia. Primary end point is a positive polymerase chain reaction(PCR)associated with clinical signs.', 'detailedDescription': 'Bacterial and fungal infection treatment is well defined with guidelines. Few data are available for viral infections and concern essentially allogeneic stem cell transplantation. These infections are associated with a high mortality and morbidity rate. Data concerning AML are essentially retrospective, pediatric and with a little number of patients. Respiratory viral infections incidence is not known. These infections may be responsible for a higher mortality rate. Different risk factors are found: age superior to 65 years, lymphopenia, co-infections. Treatment is subject to a controversy: surveillance or starting an antiviral therapy. This study aims at understanding viral infections epidemiology during long term aplasia and optimizing their management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over 18 years old with an AML diagnostic and treated with induction and consolidation chemotherapy. Patients enrolled in another protocol may be included.\n* Patients with relapsed leukemia who are treated with a salvage intensive therapy stay in the study\n* Patients who have signed a consent policyholder\n\nExclusion Criteria:\n\n* patients under 18 years old\n* patients treated with another treatment than induction and consolidation chemotherapy\n* pregnant women\n* patients HIV, HBV or HBC positive\n* patients with a positive PCR at J1\n* patients treated with an antiviral treatment or an immunosuppressive treatment for another pathology\n* patients under guardianship\n* Primitive immunity Deficit'}, 'identificationModule': {'nctId': 'NCT01819792', 'acronym': 'LAMVIRE', 'briefTitle': 'Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy', 'orgStudyIdInfo': {'id': 'PI2011_843_0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'patient with Acute Myeloïd Leukemia', 'interventionNames': ['Other: Multiplex respiratory viral PCR']}], 'interventions': [{'name': 'Multiplex respiratory viral PCR', 'type': 'OTHER', 'armGroupLabels': ['patient with Acute Myeloïd Leukemia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'Pr Marolleau', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'CHU CAEN', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'Chru Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Chu Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Jean Pierre MAROLLEAU, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU AMIENS'}, {'name': 'FABRICE JARDIN, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU ROUEN'}, {'name': 'OUMEDALY RENAN, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU CAEN'}, {'name': 'BRUNO QUESNEL, MD PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU LILLE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}