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NCT Number: NCT01819792

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

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pr Marolleau, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiplex respiratory viral PCR

Other

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

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy

Acronym: LAMVIRE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 28, 2013
Registry last updated
Apr 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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