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

NCT04099082 | Recruiting

• 1 other identifier: APHP180175
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Hematopoietic Stem Cell Recipients; Acute Respiratory Infection; Parainfluenza Virus (PIV)

Outcome Measures

Primary Outcomes (1)

• Host response in both blood and respiratory tract after PIV infection

  Up to 6 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Cases

eligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months

Other: samples

Controls

eligible patients free of 10% FEV1 decline at 2 months

Other: samples

Interventions

samples OTHER

blood sample nasal swab

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult recipients of allogeneic HSCT with PIV pulmonary infection

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Saint Louis

Paris, Île-de-France Region, 75010, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood samples nasal swab

MeSH Terms

Interventions

Sampling Studies

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

David Michonneau, MD PhD

CONTACT

1 42 49 49 49; david.michonneau@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: September 23, 2019
• Study Start: March 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: July 17, 2024

Record last verified: 2024-07

Locations

FR (1)