Understanding how bacteria and immune response affect whooping cough severity

Is this trial a fit for you?

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 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.

Why it matters

Who can join: the full rules

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 it's running

• Hôpital Louis Mourier
  Colombes, France 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 Armand Trousseau
  Paris, France Recruiting

Study contacts

• Study coordinator: Julie Toubiana, MD
• Email: julie.toubiana@pasteur.fr
• Phone: +331 45 68 80 05

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.