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

Recruiting

• Conditions: Acute Respiratory Infection; Parainfluenza Virus (PIV); Allogeneic Hematopoietic Stem Cell Recipients
• Interventions: Other: samples

• Registration Number: NCT04099082
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Start: 2021-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-17
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Controls	samples	eligible patients free of 10% FEV1 decline at 2 months
Cases	samples	eligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months

Primary Outcome Measures

Name	Time	Method
Host response in both blood and respiratory tract after PIV infection	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Saint Louis; 🇫🇷 Paris, Ile De France, France