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

Acute Myeloid Leukemia Clinical Trial

— LAMVIRE  

Official title:

Incidence of Respiratory Viral Infections During AML Induction and Consolidation Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819792
• Other study ID #: PI2011_843_0005
• Status: Completed
• Phase: Phase 4
• First received: March 18, 2013
• Last updated: April 19, 2018
• Start date: April 2013
• Est. completion date: July 2016

Study information

• Verified date: April 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Virus Diseases

Intervention

Other:
• Multiplex respiratory viral PCR

Locations

Country	Name	City	State
France	Pr Marolleau	Amiens
France	CHU CAEN	Caen
France	Chru Lille	Lille
France	Chu Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	seasonal viral infection incidence measure		18 months after inclusion
Secondary	risk factor of viral infections research		18 months after inclusion
Secondary	viral infections related morbidity and mortality estimation		18 months after inclusion
Secondary	bacterial and fungal co-infection estimation		18 months after inclusion
Secondary	description of antiviral therapeutic used for treating patients		18 months after inclusion