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

NCT ID: NCT04099082

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2025-03-01

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)

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Cases

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

samples

Intervention Type: OTHER

blood sample nasal swab

Controls

eligible patients free of 10% FEV1 decline at 2 months

samples

Intervention Type: OTHER

blood sample nasal swab

Interventions

samples

blood sample nasal swab

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Saint Louis

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

David Michonneau, MD PhD

Role: CONTACT

david.michonneau@aphp.fr

1 42 49 49 49 ext. +33

Jérôme Lambert, MD PhD

Role: CONTACT

jerome.lambert@u-paris.fr

142499742 ext. +33

Facility Contacts

David Michonneau, MD PhD

Role: primary

david.michonneau@aphp.fr

+33 1 42 49 41 66

Other Identifiers

APHP180175

Identifier Type: -

Identifier Source: org_study_id