NCT01819792

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2013

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

March 18, 2013

Last Update Submit

April 19, 2018

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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

Study Arms (1)

patient with Acute Myeloïd Leukemia

OTHER
Other: Multiplex respiratory viral PCR

Interventions

Multiplex respiratory viral PCROTHER
patient with Acute Myeloïd Leukemia

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Pr Marolleau

Amiens, 80054, France

Location

CHU CAEN

Caen, 14000, France

Location

Chru Lille

Lille, 59000, France

Location

Chu Rouen

Rouen, 76000, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2013

First Posted

March 28, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

April 23, 2018

Record last verified: 2018-04

Locations

FR(4)