Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-02-20 @ 3:33 PM
Study NCT ID:
NCT01819792
Status:
COMPLETED
Last Update Posted:
2018-04-23
First Post:
2013-03-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
Sponsor:
Centre Hospitalier Universitaire, Amiens
Organization:
Study Overview
Official Title:
Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LAMVIRE
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: