Allogeneic Hematopoietic Stem Cell RecipientsALLOPIVNCT04099082
Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans
An observational study of Allogeneic Hematopoietic Stem Cell Recipients and Acute Respiratory Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Recipients, Acute Respiratory Infection, Parainfluenza Virus (PIV)
- What is being tested?
- samples
- How many people
- 14 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2021to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult recipients of allogeneic HSCT with PIV pulmonary infection
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Saint Louis
Paris, Île-de-France Region, 75010
David Michonneau, MD PhD, +33 1 42 49 41 66, david.michonneau@aphp.fr
David Michonneau, MD PhD
About this study
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.
- Conditions
- Allogeneic Hematopoietic Stem Cell Recipients, Acute Respiratory Infection, Parainfluenza Virus (PIV)
- Being tested
- samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
samplesOther
blood sample nasal swab
| Study group | Role | What they receive |
|---|---|---|
| Cases | eligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months Receives: Other: samples | |
| Controls | eligible patients free of 10% FEV1 decline at 2 months Receives: Other: samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Host response in both blood and respiratory tract after PIV infection
Measured: Up to 6 months
Secondary outcomes (2)
Identify the cellular signaling pathways associated with the development of BO following parainfluenzae virus infection
Measured: Up to 6 months
Evaluate differences in transcriptomic profiles between blood and respiratory tract
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start1 Mar 2021
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell RecipientsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099082
- Sponsor's protocol ID
- APHP180175
- Acronym
- ALLOPIV
- Status last verified
- Jul 2024
- First submitted
- 19 Aug 2019
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Signature of the Host Response to a Respiratory Viral Infection, in the Prediction of Bronchiolitis Obliterans
- ClinicalTrials.gov ID
- NCT04099082
- Acronym / sponsor ID
- ALLOPIV / APHP180175
- Conditions
- Allogeneic Hematopoietic Stem Cell Recipients, Acute Respiratory Infection, Parainfluenza Virus (PIV)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: sampleseligible patients with 10% decline in Forced Expiratory Volume (FEV1) at 2 months |
| Controls | – | Other: sampleseligible patients free of 10% FEV1 decline at 2 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult recipients of allogeneic HSCT with PIV pulmonary infection
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| samplesblood sample nasal swab | Other | Cases, Controls |
Primary outcome
Host response in both blood and respiratory tract after PIV infection
Time frame: Up to 6 months
2 secondary outcomes
Identify the cellular signaling pathways associated with the development of BO following parainfluenzae virus infection
Time frame: Up to 6 months
Evaluate differences in transcriptomic profiles between blood and respiratory tract
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allogeneic Hematopoietic Stem Cell Recipients and Acute Respiratory Infection, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Michonneau, MD PhD (1 42 49 49 49 ext. +33, david.michonneau@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Host response in both blood and respiratory tract after PIV infection (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.