LAMVIRE: Respiratory Viral Infections During Acute Myeloid Leukemia (AML)Chemotherapy Related Aplasia
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: patient with Acute Myeloïd Leukemia
|
Other: Multiplex respiratory viral PCR
|
Outcome Measures
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 [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
- 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]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pr Marolleau | Amiens | France | 80054 | |
| 2 | CHU CAEN | Caen | France | 14000 | |
| 3 | Chru Lille | Lille | France | 59000 | |
| 4 | Chu Rouen | Rouen | France | 76000 |
Sponsors and Collaborators
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- PI2011_843_0005