Actively Recruiting

Phase Not Applicable
Age: 0 - 15Years
All Genders
NCT05897879

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

Age: 0 - 15Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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