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NCT Number: NCT04099082

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint Louis

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

Location status: Recruiting

Location contact

David Michonneau, MD PhD

CONTACT

[email protected]

+33 1 42 49 41 66

David Michonneau, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Samples

Other

blood sample nasal swab

Primary outcomes

  1. Host response in both blood and respiratory tract after PIV infection

    Time frame: Up to 6 months

Secondary outcomes

  1. Identify the cellular signaling pathways associated with the development of BO following parainfluenzae virus infection

    Time frame: Up to 6 months

  2. Evaluate differences in transcriptomic profiles between blood and respiratory tract

    Time frame: Up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

David Michonneau, MD PhD

CONTACT

[email protected]

1 42 49 49 49 ext. +33

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ALLOPIV

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2019
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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