Clinical trial NCT01819792: Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
Official title: Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myeloid Leukemia
Keywords: Acute Myeloid Leukemia
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-03-28
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: at day 15
Secondary outcomes:
measure: seasonal viral infection incidence measure
timeFrame: 18 months after inclusion
measure: risk factor of viral infections research
timeFrame: 18 months after inclusion
measure: viral infections related morbidity and mortality estimation
timeFrame: 18 months after inclusion
measure: bacterial and fungal co-infection estimation
timeFrame: 18 months after inclusion
measure: description of antiviral therapeutic used for treating patients
timeFrame: 18 months after inclusion
Other outcomes:
Locations:
city: Amiens
country: France
facility: Pr Marolleau
city: Caen
country: France
facility: CHU CAEN
city: Lille
country: France
facility: Chru Lille
city: Rouen
country: France
facility: Chu Rouen
Study officials:
affiliation: CHU AMIENS
name: Jean Pierre MAROLLEAU, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU ROUEN
name: FABRICE JARDIN, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU CAEN
name: OUMEDALY RENAN, MD PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU LILLE
name: BRUNO QUESNEL, MD PHD
role: PRINCIPAL_INVESTIGATOR
References: