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

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ClinicalTrials.gov Identifier: NCT01819792
Recruitment Status : Completed
First Posted : March 28, 2013
Last Update Posted : April 23, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Other: Multiplex respiratory viral PCR Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy
Study Start Date : April 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
patient with Acute Myeloïd Leukemia Other: Multiplex respiratory viral PCR



Primary Outcome Measures :
  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 [ Time Frame: 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 :
  1. seasonal viral infection incidence measure [ Time Frame: 18 months after inclusion ]
  2. risk factor of viral infections research [ Time Frame: 18 months after inclusion ]
  3. viral infections related morbidity and mortality estimation [ Time Frame: 18 months after inclusion ]
  4. bacterial and fungal co-infection estimation [ Time Frame: 18 months after inclusion ]
  5. description of antiviral therapeutic used for treating patients [ Time Frame: 18 months after inclusion ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819792


Locations
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France
Pr Marolleau
Amiens, France, 80054
CHU CAEN
Caen, France, 14000
Chru Lille
Lille, France, 59000
Chu Rouen
Rouen, France, 76000
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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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

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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01819792     History of Changes
Other Study ID Numbers: PI2011_843_0005
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018
Keywords provided by Centre Hospitalier Universitaire, Amiens:
Acute Myeloid Leukemia
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Virus Diseases
Neoplasms by Histologic Type
Neoplasms