Informations générales (source: ClinicalTrials.gov)
Impact of Bacterial Expression and Immune Response in the Severity of Pertussis (PERT-SEVEREII)
Interventional
N/A
Institut Pasteur (Voir sur ClinicalTrials)
novembre 2023
novembre 2026
29 juin 2024
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 with pertussis will be used to identify
1. 'in situ' expression profiles of B. pertussis genes and proteins incorporating
recent evolutionary changes and
2. a systemic and respiratory immune signature in B. pertussis-infected children
according to severity.
Results should furthermore serve as a prerequisite for the identification of severity
biomarkers and new vaccine antigen candidates taking into account specific immune
responses in infants.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Armand Trousseau-La Roche Guyon | Mathie Lorrot, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Louis Mourier | Romain Basmaci, MD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Necker-Enfants Malades | Julie Toubiana, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier intercommunal de Créteil - Créteil - France | Fouad Madhi, MD | Contact (sur clinicalTrials) | |||
| CHU de Bordeaux - Bordeaux - France | Emilie Pauquet, MD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Nantes - France | David Malorey, MD | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Toulouse - France | Camille Brehin, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen - Rouen - France | Didier Pinquier, MD | Contact (sur clinicalTrials) | |||
| Hôpital de la Timone Enfants, APHM - Marseille - France | Aurélie Morand, MD | Contact (sur clinicalTrials) | |||
| Hôpital Nord, APHM - Marseille - France | Philippe Minodier, MD | Contact (sur clinicalTrials) | |||
| Hôpital Robert Debré - Paris - France | Albert Faye, MD | Contact (sur clinicalTrials) | |||
| Hôpital Roger Salengo - Lille - France | François Dubos, MD | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Lyon - France | Antoine Ouziel, MD | Contact (sur clinicalTrials) | |||
| Réseau ACTIV - Saint-Maur-des-Fossés - France | Robert Cohen, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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.