Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia

Phase 4CompletedNCT01819792

Centre Hospitalier Universitaire, Amiens119 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

119

Conditions

Acute Myeloid Leukemia

Interventions

Multiplex respiratory viral PCROTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 18 years old with an AML diagnostic and treated with induction and consolidation chemotherapy. Patients enrolled in another protocol may be included. * Patients with relapsed leukemia who are treated with a salvage intensive therapy stay in the study * Patients who have signed a consent policyholder Exclusion Criteria: * patients under 18 years old * patients treated with another treatment than induction and consolidation chemotherapy * pregnant women * patients HIV, HBV or HBC positive * patients with a positive PCR at J1 * patients treated with an antiviral treatment or an immunosuppressive treatment for another pathology * patients under guardianship * Primitive immunity Deficit

Locations (4)

Pr Marolleau

Amiens, France

CHU CAEN

Caen, France

Chru Lille

Lille, France

Chu Rouen

Rouen, France

Outcomes

Primary Outcomes

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