Clinical trial NCT04099082: Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans
Official title: Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allogeneic Hematopoietic Stem Cell Recipients
Acute Respiratory Infection
Parainfluenza Virus (PIV)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult recipients of allogeneic HSCT with PIV pulmonary infection

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.


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

Primary outcomes:
measure: Host response in both blood and respiratory tract after PIV infection
timeFrame: Up to 6 months
Secondary outcomes:
measure: Identify the cellular signaling pathways associated with the development of BO following parainfluenzae virus infection
timeFrame: Up to 6 months
measure: Evaluate differences in transcriptomic profiles between blood and respiratory tract
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Louis
state: Ile De France
Study officials:
References: