Actively Recruiting
Impact of Bacterial Expression and Immune Response in the Severity of Pertussis
Led by Institut Pasteur · Updated on 2024-05-24
210
Participants Needed
14
Research Sites
156 weeks
Total Duration
On this page
Sponsors
I
Institut Pasteur
Lead Sponsor
H
Hôpital Necker-Enfants Malades
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Bacterial Expression and Immune Response in the Severity of Pertussis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be between the ages of 0 and 15 years inclusive
- Be suspected of having pertussis by a physician with a diagnostic PCR test prescribed
- Be free of pathologies or treatments that may affect the immune response, such as autoimmune or inflammatory diseases, immune deficiencies, or liver failure
- Have received age-appropriate information and written consent from parents or legal guardians
- Be affiliated with or benefit from a social security plan
You will not qualify if you...
- Have any pathology or treatment influencing the immune response, including autoimmune or inflammatory diseases, immune deficiencies, liver failure, or immunosuppressive therapy like oral corticosteroids at doses of 10 mg/day or more for over 15 days
- Have used antibiotics active against pertussis within 24 hours before sampling
- Have a delay longer than 48 hours between diagnostic PCR result and study inclusion
- Have a condition that makes additional sampling unsafe as judged by the physician
- Be an infant weighing less than 2.5 kg at the time of inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
CHU de Bordeaux
Bordeaux, France
Not Yet Recruiting
2
Hôpital Louis Mourier
Colombes, France
Actively Recruiting
3
Centre hospitalier intercommunal de Créteil
Créteil, France
Not Yet Recruiting
4
Hôpital Roger Salengo
Lille, France
Actively Recruiting
5
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
6
Hôpital de la Timone Enfants, APHM
Marseille, France
Actively Recruiting
7
Hôpital Nord, APHM
Marseille, France
Actively Recruiting
8
CHU de Nantes
Nantes, France
Not Yet Recruiting
9
CHU Armand Trousseau
Paris, France
Actively Recruiting
10
Hopital Necker
Paris, France
Actively Recruiting
11
Hôpital Robert Debré
Paris, France
Not Yet Recruiting
12
CHU Rouen
Rouen, France
Not Yet Recruiting
13
Réseau ACTIV
Saint-Maur-des-Fossés, France
Not Yet Recruiting
14
CHU de Toulouse
Toulouse, France
Actively Recruiting
Research Team
J
Julie Toubiana, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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