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

Phase 4

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Other: Multiplex respiratory viral PCR

• Registration Number: NCT01819792
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Study Timeline

• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-25
• Study First Posted: 2013-03-28
• Study Start: 2013-04
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with Acute Myeloïd Leukemia	Multiplex respiratory viral PCR	-

Primary Outcome Measures

Name	Time	Method
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs	at day 15	Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.

Secondary Outcome Measures

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

Trial Locations

Locations (4)

CHU CAEN; 🇫🇷 Caen, France

Pr Marolleau; 🇫🇷 Amiens, France

Chu Rouen; 🇫🇷 Rouen, France

Chru Lille; 🇫🇷 Lille, France