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

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ClinicalTrials.gov Identifier: NCT04099082
Recruitment Status : Not yet recruiting
First Posted : September 23, 2019
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment
Allogeneic Hematopoietic Stem Cell Recipients Acute Respiratory Infection Parainfluenza Virus (PIV) Other: samples

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Study Type : Observational
Estimated Enrollment : 14 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans
Estimated Study Start Date : March 15, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases
eligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months
Other: samples
blood sample nasal swab

Controls
eligible patients free of 10% FEV1 decline at 2 months
Other: samples
blood sample nasal swab




Primary Outcome Measures :
  1. Host response transcriptomic signature in both blood and respiratory tract after PIV infection [ Time Frame: at the time of BO, through study completion, an average of 1 year ]

Biospecimen Retention:   Samples With DNA
blood samples nasal swab


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult recipients of allogeneic HSCT with PIV pulmonary infection
Criteria

Inclusion Criteria:

  • Adult recipients of allogeneic HSCT
  • Pulmonary infection with PIV

Exclusion Criteria:

  • No health care insurance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099082


Contacts
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Contact: A Bergeron-Lafaurie, MD PhD 33 1 42 49 49 49 anne.bergeron-lafaurie@aphp.fr
Contact: S Cassonnet 43 1 42 49 49 49

Locations
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France
Saint Louis
Paris, Ile De France, France, 75010
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04099082    
Other Study ID Numbers: APHP180175
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Paramyxoviridae Infections
Bronchiolitis
Bronchiolitis Obliterans
Virus Diseases
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Mononegavirales Infections
RNA Virus Infections