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

Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Other: Multiplex respiratory viral PCR

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 Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Pr Marolleau
  • Caen, France, 14000
    • CHU Caen
  • Lille, France, 59000
    • CHRU Lille
  • Rouen, France, 76000
    • CHU Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: patient with Acute Myeloïd Leukemia	Other: Multiplex respiratory viral PCR

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Jean Pierre MAROLLEAU, MD PHD, CHU Amiens; Principal Investigator: FABRICE JARDIN, MD PHD, CHU Rouen; Principal Investigator: OUMEDALY RENAN, MD PHD, CHU Caen; Principal Investigator: BRUNO QUESNEL, MD PHD, CHRU Lille

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 18, 2013
• First Submitted That Met QC Criteria: March 25, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Actual): April 23, 2018
• Last Update Submitted That Met QC Criteria: April 19, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Acute Myeloid Leukemia
• Additional Relevant MeSH Terms: Infections; Neoplasms by Histologic Type; Neoplasms; Virus Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: PI2011_843_0005