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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 4

Conditions: Acute Myeloid Leukemia

Treatments: Other: Multiplex respiratory viral PCR

Study type: Interventional

Funder types: Other

Identifiers

NCT01819792

PI2011_843_0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 119 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

patient with Acute Myeloïd Leukemia

Other group

Treatment:

Other: Multiplex respiratory viral PCR