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NCT04099082 Clinical Trial

Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans

Acute Respiratory Infection Clinical Trial

— ALLOPIV  

Official title:
Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04099082
Other study ID # APHP180175
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 15, 2020
Est. completion date December 31, 2021

Study information
Verified date February 2020
Source Assistance Publique - Hôpitaux de Paris
Contact A Bergeron-Lafaurie, MD PhD
Phone 33 1 42 49 49 49
Email anne.bergeron-lafaurie@aphp.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bronchiolitis obliterans (BO) is the well-known manifestation of the chronic pulmonary graft-versus-host disease(GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT). The pathophysiology of BO is, however, poorly known. The available data strongly support the role of respiratory viruses, in particular paramyxoviruses (parainfluenzae virus (PIV), respiratory syncytial virus, metapneumovirus). It is likely that the alloimmune response triggered by the respiratory virus is inadequate and leads to the peribronchiolar fibrotic process. The objective is to analyze the kinetics of profiles of the blood and respiratory host responses resulting from a high or low parainfluenza respiratory infection, in order to evaluate if the occurrence of a BO is associated with a specific signature We will evaluate the predictive signature of a BO after a parainfluenza virus infection by characterizing the differences between the patients evolving and those not evolving to a BO at 2 months after the infection.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 14
Est. completion date December 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult recipients of allogeneic HSCT

- Pulmonary infection with PIV

Exclusion Criteria:

- No health care insurance

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• samples
blood sample nasal swab

Locations
Country Name City State
France Saint Louis Paris Ile De France

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Host response transcriptomic signature in both blood and respiratory tract after PIV infection at the time of BO, through study completion, an average of 1 year
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