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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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patient with Acute Myeloïd Leukemia

Group Type OTHER

Multiplex respiratory viral PCR

Intervention Type OTHER

Interventions

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Multiplex respiratory viral PCR

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No