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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Respiratory Infection; Allogeneic Hematopoietic Stem Cell Recipients; Parainfluenza Virus (PIV)
• Intervention / Treatment: Other: samples

• Study Type: Observational
• Enrollment (Estimated): 14

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: David Michonneau, MD PhD; Phone Number: +33 1 42 49 49 49; Email: david.michonneau@aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75010
      • Recruiting
      • Saint Louis
      • Contact: David Michonneau, MD PhD; Phone Number: +33 1 42 49 41 66; Email: david.michonneau@aphp.fr
      • Principal Investigator: David Michonneau, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult recipients of allogeneic HSCT with PIV pulmonary infection

Description

Inclusion Criteria :

• Adults having received a hematopoietic stem cell transplantation for less than two years
• Availability of respiratory function tests prior to infection
• Presence of PIV respiratory infection documented by identification of the virus by PCR in the upper and/or lower respiratory tract
• Symptoms of respiratory infection ≤ 5 days
• Signed informed consent

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; eligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months	Other: samples; blood sample nasal swab
Controls; eligible patients free of 10% FEV1 decline at 2 months	Other: samples; blood sample nasal swab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Host response in both blood and respiratory tract after PIV infection	Up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: September 19, 2019
• First Posted (Actual): September 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 17, 2024
• Last Update Submitted That Met QC Criteria: July 15, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Mononegavirales Infections; Lung Diseases, Obstructive; Bronchitis; Organizing Pneumonia; Graft vs Host Disease; Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; Bronchiolitis; Bronchiolitis Obliterans; Paramyxoviridae Infections; Bronchiolitis Obliterans Syndrome
• Other Study ID Numbers: APHP180175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No