Understanding the respiratory microbiomes in infants with severe asthma
Official title: Dynamique Des Microbiomes Respiratoires Des Voies supérieures et inférieures associée à l'Asthme sévère Des Nourrissons
Run by University Hospital, Rouen · NCT06044051 · Data updated 2026-11-12
This study is trying to understand the germs in the lungs of infants with severe asthma to see if a common antibiotic can help improve their condition.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 24 Months |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Status | Recruiting |
| Started | September 26, 2023 |
| Main results expected | September 26, 2026 |
| Study ends | September 26, 2026 |
| Registry record updated | February 17, 2026 |
| Trial ID | NCT06044051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants under 24 months old who are being followed by a pneumo-pediatrician for severe asthma.
✕Probably not a fit
Patients with chronic respiratory diseases other than infant asthma or those currently on antibiotic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the dynamics of the upper and lower airway microbiomes in infants suffering from severe asthma. It aims to explore the potential dysbiosis and the interrelation of different microbiomes in the respiratory tract, as well as the immune system's role in the development of severe asthma. By analyzing blood samples, expectoration, and nasopharyngeal swabs, the study seeks to uncover new therapeutic targets and improve patient care, particularly focusing on the use of azithromycin as an immunomodulator. The findings could lead to better management strategies for infant asthma.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and management strategies for infants with severe asthma.
How similar studies have gone: While this approach is innovative, similar studies exploring the microbiome's role in asthma have shown promise, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Rouen University Hospital
Rouen, France Recruiting
Study contacts
- Principal investigator: PETAT Hortense — University Hospital, Rouen
- Study coordinator: David Mallet
- Email: secretariat.DRC@chu-rouen.fr
- Phone: 02 32 88 82 65
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.