Actively Recruiting

Age: 18Years +
All Genders
ID04099082

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-07-17

14

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This observational study focuses on adults who have undergone allogeneic hematopoietic stem cell transplantation (HSCT) within the past two years and who develop respiratory infections caused by parainfluenza virus (PIV). Researchers aim to understand how the body's blood and respiratory responses to PIV infection may predict the development of bronchiolitis obliterans (BO), a chronic lung condition linked to graft-versus-host disease after HSCT. The study explores the immune reactions and cellular pathways involved in this process. Participants are monitored after a documented PIV respiratory infection confirmed by PCR testing. They are grouped based on whether they experience a 10% decline in lung function, measured by Forced Expiratory Volume (FEV1), two months after infection. Throughout the study, blood samples and nasal swabs are collected to analyze host responses in both the blood and respiratory tract over a period of up to six months. During the study, participants undergo respiratory function tests and provide biological samples to help identify differences in immune and transcriptomic profiles between those who develop BO and those who do not. The primary outcome measures include tracking the host response in blood and respiratory tissues, while secondary outcomes assess cellular signaling pathways and transcriptomic differences. The study spans up to six months of follow-up after infection to evaluate these outcomes comprehensively.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults having received a hematopoietic stem cell transplantation for less than two years
  • Availability of respiratory function tests prior to infection
  • Presence of parainfluenza virus respiratory infection documented by PCR in the upper and/or lower respiratory tract
  • Symptoms of respiratory infection lasting 5 days or less
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of a respiratory virus infection other than parainfluenza virus
  • Viral respiratory co-infections
  • Bacterial or fungal respiratory infections
  • Treatment with ribavirin, oseltamivir, or any other antiviral active against respiratory viruses
  • Patient not affiliated or beneficiary of a social security system
  • Patient deprived of liberty or protected
  • Pregnant or breastfeeding woman

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 6 months

Participants provide blood samples and nasal swabs to study the host response to parainfluenza virus infection.

Visits scheduled as needed during the 6 months

Long-term Monitoring

Duration - Up to 6 months

Participants are monitored to evaluate changes in respiratory function and cellular signaling pathways related to bronchiolitis obliterans development.

Follow-up visits during the 6 months period

Trial Site Locations

Total: 1 location

1

Saint Louis

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

Actively Recruiting

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Research Team

D

David Michonneau, MD PhD

J

Jérôme Lambert, MD PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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