Dynamics of the Upper and Lower Airway Respiratory Microbiomes Associated With Severe Infant Asthma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 24
SponsorUniversity Hospital, Rouen
About this trial
Nature of potential dysbiosis, interrelation of the different microbiomes of the respiratory tract, and potential role of the immune system in the pathogenesis of severe asthma in infants, and its evolution under treatment.
Exploring and understanding these data is to improve patient care and discover new therapeutic targets.
The aim is to open up prospects for therapeutic studies, such as the use of azithromycin as an immunomodulator in infant asthma, the results of which are discordant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants less than 24 months old
Follow-up by a pneumo-pediatrician for severe asthma in infants
Requiring etiological investigations and assessment of severity in day hospitalization, including bronchial fibroscopy (HAS 2009)
Parent informed of the research and having signed consent
Disqualifiers
Prematurity <32 WA
Congenital heart disease with significant left to right shunt
Chronic respiratory disease other than infant asthma (cystic fibrosis, bronchiolitis obliterans)
Antibiotic therapy in progress or administered the seven days preceding the date of inclusion (day hospitalization)
Trial design
Design model
Single group
Treatments tested in this trial
Blood sample
Other interventionAn additionnal volume of blood will be collected at inclusion and at each follow-up visit
Expectoration
Other interventionExpectoration will be collected at inclusion and at each follow-up visit
Nasopharyngeal swab
Other interventionA nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: All patientsOther 3 interventions
Trial outcomes
Primary outcomes
1
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids - NGS sequencing
Time frame
Inclusion2
description of microbiomes from nasopharyngeal samples
analysis of nasopharyngeal samples- NGS sequencing
Time frame
Inclusion3
description of microbiomes from sputum samples
analysis of sputum samples- NGS sequencing
Time frame
Inclusion4
description of microbiomes from bronchoalveolar fluids
analysis of bronchoalveolar fluids- NGS sequencing
Time frame
at 3 monthsSponsors and contacts
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Source ClinicalTrials.gov