Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00004-41 | Other Identifier | ID RCB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hôpital Necker-Enfants Malades | OTHER |
| Hospices Civils de Lyon | OTHER |
| Hopital Universitaire Robert-Debre | OTHER |
| Centre Hospitalier Intercommunal Creteil |
Not provided
Not provided
Not provided
Not provided
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
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.
The study design is characterized by 4 work packages:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children between 0 and 15 years with suspected pertussis | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasopharyngeal swab | Biological | For hospitalized patients : Nasopharyngeal swab (1 aspiration or 2 swabs (1 in each nostril)) For ambulatory patients : Deep nasal swab: 2 swabs (1 in each nostril), or 1 swab only for children for whom taking 2 swabs is complicated. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of expression level of Bp genes during infection by Nanostring transcriptomic analysis of Bp isolates from the nasopharynx of children with pertussis. | To identify in a standardized way the microbial "in situ" expression profiles of currently circulating Bp genes during infection in children ; | 3 years |
| Measurement of plasma cytokine and chemokine concentrations by SIMOA digital ELISA | To determine systemic and respiratory immune responses in children during pertussis. | 3 years |
| Phenotyping of immune cells by cytometry with a 20-color flow cytometry panel | To determine systemic and respiratory immune responses in children during pertussis. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of expression level of Bp genes which is modified by recent gene developments related to vaccine pressure by Nanostring transcriptomic analysis of Bp isolates | List of microbial genes which expression is modified by recent genomic developments related to vaccine pressure | 3 years |
| Measurement of high expression level of Bp genes in all clinical forms of pertussis by Nanostring transcriptomic analysis of Bp isolates |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julie Toubiana, MD | Contact | +331 45 68 80 05 | julie.toubiana@pasteur.fr |
| Name | Affiliation | Role |
|---|---|---|
| Julie Toubiana, MD | Institut Pasteur | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Not yet recruiting | Bordeaux | France |
Not provided
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
| OTHER |
| Nantes University Hospital | OTHER |
| Réseau ACTIV | UNKNOWN |
| Hôpital Armand Trousseau | OTHER |
| CHR - Hôpital Roger Salengo | UNKNOWN |
| Hôpital Nord - APHM | UNKNOWN |
| Hôpital Louis Mourier | OTHER |
| University Hospital, Toulouse | OTHER |
| University Hospital, Bordeaux | OTHER |
| Hôpital de la Timone | OTHER |
| University Hospital, Rouen | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood samples | Biological | For hospitalized patients : 3 to 7.5 ml For ambulatory patients: Fingertip blood sampling |
|
To identify new candidate Bp genes for a future protein vaccine |
| 3 years |
| Measurement of expression level of Bp genes which is associated with severe pertussis by Nanostring transcriptomic analysis of Bp isolates | List of virulence genes differentially expressed during severe pertussis | 3 years |
| Hôpital Louis Mourier | Recruiting | Colombes | France |
|
| Centre hospitalier intercommunal de Créteil | Not yet recruiting | Créteil | France |
|
| Hôpital Roger Salengo | Recruiting | Lille | France |
|
| Hospices Civils de Lyon | Recruiting | Lyon | France |
|
| Hôpital de la Timone Enfants, APHM | Recruiting | Marseille | France |
|
| Hôpital Nord, APHM | Recruiting | Marseille | France |
|
| CHU de Nantes | Not yet recruiting | Nantes | France |
|
| CHU Armand Trousseau | Recruiting | Paris | France |
|
| Hopital Necker | Recruiting | Paris | France |
|
| Hôpital Robert Debré | Not yet recruiting | Paris | France |
|
| CHU Rouen | Not yet recruiting | Rouen | France |
|
| Réseau ACTIV | Not yet recruiting | Saint-Maur-des-Fossés | France |
|
| CHU de Toulouse | Recruiting | Toulouse | France |
|
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |