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Clinical Trials/NCT04099082
NCT04099082
Recruiting
Not Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country14 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Allogeneic Hematopoietic Stem Cell Recipients
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
14
Locations
1
Primary Endpoint
Host response in both blood and respiratory tract after PIV infection
Status
Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
March 1, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Presence of a respiratory virus infection other than PIV
  • Viral respiratory co-infections
  • Bacterial or fungal respiratory infections
  • Treatment with ribavirin, oseltamivir or any other antiviral with activity against respiratory viruses
  • Patient not affiliated or beneficiary of a social security system
  • Patient deprived of liberty or protected
  • Pregnant or breastfeeding woman

Outcomes

Primary Outcomes

Host response in both blood and respiratory tract after PIV infection

Time Frame: Up to 6 months

Secondary Outcomes

  • Evaluate differences in transcriptomic profiles between blood and respiratory tract(Up to 6 months)
  • Identify the cellular signaling pathways associated with the development of BO following parainfluenzae virus infection(Up to 6 months)

Study Sites (1)

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