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

• Sponsor: Assistance Publique - Hôpitaux de Paris (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04099082
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Anticipated Duration (Months): 21.6
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase
Allogeneic Hematopoietic Stem Cell Recipients; Acute Respiratory Infection; Parainfluenza Virus (PIV)	Other: samples

Study Design

• Study Type: Observational
• Anticipated 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
• Anticipated Study Start Date: Mar 15, 2020
• Anticipated Primary Completion Date: Aug 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult recipients of allogeneic HSCT

• Pulmonary infection with PIV

Exclusion Criteria:

• No health care insurance

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Saint Louis	Paris	Ile De France	France	75010

Sponsors and Collaborators

• Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique - Hôpitaux de Paris
• ClinicalTrials.gov Identifier: NCT04099082
• Other Study ID Numbers: APHP180175
• First Posted: Sep 23, 2019
• Last Update Posted: Feb 10, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Bronchiolitis; Respiratory Tract Infections; Virus Diseases; Paramyxoviridae Infections; Bronchiolitis Obliterans

Study Results

No Results Posted as of Feb 10, 2020