ClinicalTrials.gg
RecruitingNCT04099082ALLOPIVUpdated Jul 17, 2024

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

An observational study in Allogeneic Hematopoietic Stem Cell Recipients, Acute Respiratory Infection and Parainfluenza Virus (PIV), sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-17.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2021; still recruiting 5 years 8 months later.

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
14
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allogeneic Hematopoietic Stem Cell Recipients
  • Acute Respiratory Infection
  • Parainfluenza Virus (PIV)
03

In context

Paramyxoviridae Infections

31 studies on the registry are indexed under Paramyxoviridae Infections; 3 are open to participants now.

Browse Paramyxoviridae Infections studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,596 studies on the registry; 1,037 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult recipients of allogeneic HSCT with PIV pulmonary infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
14 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Othersamples

    blood sample nasal swab

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2021 (actual). Primary completion is estimated for Mar 2025, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2019
First posted
Sep 23, 2019
StartActual
Mar 1, 2021
Primary completionEst.
Mar 1, 2025
CompletionEst.
Mar 1, 2025
Last update
Jul 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04099082
Responsible party
Sponsor
First posted
Sep 23, 2019
Start date
Mar 1, 2021
Primary completion
Mar 1, 2025 (estimated)
Completion
Mar 1, 2025 (estimated)
Last update
Jul 17, 2024

Study contacts

David Michonneau, MD PhD
Contact
david.michonneau@aphp.fr
1 42 49 49 49 ext. +33
Jérôme Lambert, MD PhD
Contact
jerome.lambert@u-paris.fr
142499742 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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