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Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy


Phase 4
18 Years
85 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy


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.


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs

Outcome Description:

Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.

Outcome Time Frame:

at day 15

Safety Issue:

No

Principal Investigator

Jean Pierre MAROLLEAU, MD PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU AMIENS

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

PI2011-843-0005

NCT ID:

NCT01819792

Start Date:

April 2013

Completion Date:

October 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Myeloid Leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Virus Diseases

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