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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06044051
Other study ID # 2023/0091/OB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 26, 2023
Est. completion date September 26, 2026

Study information

Verified date December 2023
Source University Hospital, Rouen
Contact David Mallet
Phone 02 32 88 82 65
Email secretariat.DRC@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date September 26, 2026
Est. primary completion date September 26, 2026
Accepts healthy volunteers No
Gender All
Age group N/A to 24 Months
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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) - Refusal of bronchial fibroscopy

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Blood sample
An additionnal volume of blood will be collected at inclusion and at each follow-up visit
Expectoration
Expectoration will be collected at inclusion and at each follow-up visit
Nasopharyngeal swab
A nasopharyngeal swab will be collected at inclusion and at each follow-up visit after an induced sputum

Locations

Country Name City State
France Rouen University Hospital Rouen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary description of microbiomes from bronchoalveolar fluids analysis of bronchoalveolar fluids - NGS sequencing Inclusion
Primary description of microbiomes from nasopharyngeal samples analysis of nasopharyngeal samples- NGS sequencing Inclusion
Primary description of microbiomes from sputum samples analysis of sputum samples- NGS sequencing Inclusion
Primary description of microbiomes from bronchoalveolar fluids analysis of bronchoalveolar fluids- NGS sequencing at 3 months
Primary description of microbiomes from nasopharyngeal samples analysis of nasopharyngeal samples- NGS sequencing at 3 months
Primary description of microbiomes from sputum samples analysis of sputum samples- NGS sequencing at 3 months
Primary description of microbiomes from bronchoalveolar fluids analysis of bronchoalveolar fluids- NGS sequencing at 6 months
Primary description of microbiomes from nasopharyngeal samples analysis of nasopharyngeal samples- NGS sequencing at 6 months
Primary description of microbiomes from sputum samples analysis of sputum samples- NGS sequencing at 6 months
Primary description of microbiomes from bronchoalveolar fluids analysis of bronchoalveolar fluids - NGS sequencing at 9 months
Primary description of microbiomes from nasopharyngeal samples analysis of nasopharyngeal samples- NGS sequencing at 9 months
Primary description of microbiomes from sputum samples analysis of sputum samples- NGS sequencing at 9 months
Primary description of microbiomes from bronchoalveolar fluids analysis of bronchoalveolar fluids- NGS sequencing at 12 months
Primary description of microbiomes from nasopharyngeal samples analysis of nasopharyngeal samples- NGS sequencing at 12 months
Primary Description of microbiomes from sputum samples analysis of sputum samples- NGS sequencing at 12 months
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