A Phase 4 interventional study of Multiplex respiratory viral PCR in Acute Myeloid Leukemia, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 4 sites in France. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-04-23.
Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 4, Interventional, and Other
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.
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.
914 studies on the registry are indexed under Virus Diseases; 110 are open to participants now.
This study's enrollment of 119 is above the median of 102 across 604 interventional studies indexed under Virus Diseases.
Browse Virus Diseases studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
Other: Multiplex respiratory viral PCR
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs
Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.
Time frame: at day 15
seasonal viral infection incidence measure
Time frame: 18 months after inclusion
risk factor of viral infections research
Time frame: 18 months after inclusion
viral infections related morbidity and mortality estimation
Time frame: 18 months after inclusion
bacterial and fungal co-infection estimation
Time frame: 18 months after inclusion
description of antiviral therapeutic used for treating patients
Time frame: 18 months after inclusion
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire, Amiens