This trial is active, not recruiting.

Condition acute myeloid leukemia
Treatment multiplex respiratory viral pcr
Phase phase 4
Sponsor Centre Hospitalier Universitaire, Amiens
Start date April 2013
End date June 2017
Trial size 115 participants
Trial identifier NCT01819792, PI2011_843_0005


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
multiplex respiratory viral pcr

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
time frame: at day 15

Secondary Outcomes

seasonal viral infection incidence measure
time frame: 18 months after inclusion
risk factor of viral infections research
time frame: 18 months after inclusion
viral infections related morbidity and mortality estimation
time frame: 18 months after inclusion
bacterial and fungal co-infection estimation
time frame: 18 months after inclusion
description of antiviral therapeutic used for treating patients
time frame: 18 months after inclusion

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
Principal investigator Jean Pierre MAROLLEAU, MD PHD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Centre Hospitalier Universitaire, Amiens.