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

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Multiplex respiratory viral PCR
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Myeloid Leukemia focused on measuring Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pr Marolleau
  • CHU CAEN
  • Chru Lille
  • Chu Rouen

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patient with Acute Myeloïd Leukemia

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

seasonal viral infection incidence measure
risk factor of viral infections research
viral infections related morbidity and mortality estimation
bacterial and fungal co-infection estimation
description of antiviral therapeutic used for treating patients

Full Information

First Posted
March 18, 2013
Last Updated
April 19, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01819792
Brief Title
Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
Acronym
LAMVIRE
Official Title
Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
119 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patient with Acute Myeloïd Leukemia
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Multiplex respiratory viral PCR
Primary Outcome Measure Information:
Title
positivity of the viral PCR in the presence of clinical signs during periods of positivity of the PCR in the presence of clinical signs
Description
Positivity of the viral PCR in the presence of clinical signs during periods of Aplasia following chemotherapy induction and consolidation defining viral infection.
Time Frame
at day 15
Secondary Outcome Measure Information:
Title
seasonal viral infection incidence measure
Time Frame
18 months after inclusion
Title
risk factor of viral infections research
Time Frame
18 months after inclusion
Title
viral infections related morbidity and mortality estimation
Time Frame
18 months after inclusion
Title
bacterial and fungal co-infection estimation
Time Frame
18 months after inclusion
Title
description of antiviral therapeutic used for treating patients
Time Frame
18 months after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Pierre MAROLLEAU, MD PHD
Organizational Affiliation
CHU AMIENS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
FABRICE JARDIN, MD PHD
Organizational Affiliation
CHU ROUEN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
OUMEDALY RENAN, MD PHD
Organizational Affiliation
CHU CAEN
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
BRUNO QUESNEL, MD PHD
Organizational Affiliation
CHRU LILLE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pr Marolleau
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
CHU CAEN
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Chru Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Chu Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France

12. IPD Sharing Statement

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

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