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

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

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

Treatments

Other: samples

Study type

Observational

Funder types

Other

Identifiers

NCT04099082
APHP180175

Details and patient eligibility

About

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.

Enrollment

14 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

14 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jérôme Lambert, MD PhD; David Michonneau, MD PhD

Data sourced from clinicaltrials.gov

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