Understanding how bacteria and immune response affect whooping cough severity
Impact of Bacterial Expression and Immune Response in the Severity of Pertussis
This study is trying to understand how bacteria and the immune system affect the severity of whooping cough in children, especially infants, to find out why some get sicker than others.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 210 (estimated) |
| Ages | N/A to 15 Years |
| Sex | All |
| Sponsor | Institut Pasteur Industry-sponsored |
| Drugs / interventions | Prednisone |
| Locations | 14 sites (Bordeaux and 13 other locations) |
| Trial ID | NCT05897879 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between bacterial gene expression and immune response in children with pertussis, also known as whooping cough. It employs a comprehensive approach that includes collecting clinical data and biological samples from participants, analyzing the gene expression of Bordetella pertussis strains, and studying the immune response during infection. The goal is to identify factors that contribute to the variability in disease severity, particularly in infants who are at high risk. By utilizing advanced transcriptomic techniques, the study aims to uncover biomarkers that could predict disease outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0 to 15 years who are suspected of having pertussis and are undergoing diagnostic testing.
Not a fit: Patients with conditions that significantly affect the immune response, such as autoimmune diseases or those on immunosuppressive treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and management of pertussis, potentially enhancing vaccine effectiveness and reducing severe cases in infants.
How similar studies have performed: While the study addresses a critical gap in understanding pertussis, similar approaches in other infectious diseases have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * be between the ages of 0 and 15 years inclusive * be suspected of having pertussis by the physician in charge, with the prescription of a diagnostic PCR (pertussis PCR, which may be a syndromic PCR, a PCR targeting IS481 and/or IS1001) * be free of any pathology/treatment that may influence the immune response (autoimmune/inflammatory pathology or immune deficiency not listed above, hepatic insufficiency, taking immunosuppressive treatment (including taking oral corticosteroids with a dose ≥ 10 mg/d Prednisone equivalent for more than 15 days) * Have received age-appropriate information and written assent or consent from their parents/legal guardians * be affiliated with or benefiting from a social security plan Exclusion Criteria: * Patient with any pathology/treatment that may influence the immune response (autoimmune/inflammatory pathology or immune deficiency not listed above, hepatic failure, taking immunosuppressive therapy (including oral corticosteroids with dose ≥ 10 mg/d prednisone equivalent for more than 15 days) * Use of antibiotics active against pertussis in the 24 hours preceding the sampling * Delay between the result of the diagnostic sample (pertussis PCR) and the day of inclusion \> 48 hours * Patient's condition that, in the opinion of the physician, is incompatible with the expanded/additional sampling(s) required by the study * Infant with a weight \< 2.5 kg at the time of inclusion.
Where this trial is running
Bordeaux and 13 other locations
- CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
- Hôpital Louis Mourier — Colombes, France (Recruiting)
- Centre hospitalier intercommunal de Créteil — Créteil, France (Not_yet_recruiting)
- Hôpital Roger Salengo — Lille, France (Recruiting)
- Hospices Civils de Lyon — Lyon, France (Recruiting)
- Hôpital de la Timone Enfants, APHM — Marseille, France (Recruiting)
- Hôpital Nord, APHM — Marseille, France (Recruiting)
- CHU de Nantes — Nantes, France (Not_yet_recruiting)
- CHU Armand Trousseau — Paris, France (Recruiting)
- Hopital Necker — Paris, France (Recruiting)
- Hôpital Robert Debré — Paris, France (Not_yet_recruiting)
- CHU Rouen — Rouen, France (Not_yet_recruiting)
- Réseau ACTIV — Saint-Maur-des-Fossés, France (Not_yet_recruiting)
- CHU de Toulouse — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Julie Toubiana, MD
- Email: julie.toubiana@pasteur.fr
- Phone: +331 45 68 80 05
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.