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Impact of Bacterial Expression and Immune Response in the Severity of Pertussis

RecruitingNAAges any - 15 YearsAllInstitut Pasteur
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In plain words

What the trial is, and whether it could suit you

The resurgence of pertussis is associated with an evolutionary mechanism under the pressure of current acellular vaccines, with a possible impact on vaccine effectiveness and disease expression. Little is known about the mechanisms involved in the clinical variability of pertussis, including its most severe malignant form observed in infants (mortality between 50-80%). The main challenges are: (i) the lack of knowledge about the gene expression of B. pertussis strains currently circulating during human infection, incorporating evolutionary changes and vaccine-induced selective pressure; (ii) the poor understanding of the variability in clinical expression of pertussis, and (iii) the lack of biomarkers to predict disease severity or prognosis in infants. An integrative strategy combining a clinical, microbiological, immunological and 'omic' approach from a prospective cohort of children

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Nasopharyngeal swab
  • Blood samples
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Where

14 sites
CHU de Bordeaux
Bordeaux, France
Hôpital Louis Mourier
Colombes, France
Centre hospitalier intercommunal de Créteil
Créteil, France
Hôpital Roger Salengo
Lille, France
Hospices Civils de Lyon
Lyon, France
Hôpital de la Timone Enfants, APHM
Marseille, France
Hôpital Nord, APHM
Marseille, France
CHU de Nantes
Nantes, France

…and 6 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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