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Bordetella Pertussis, Whooping CoughPERT-SEVEREIINCT05897879

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

A study testing Nasopharyngeal swab and Blood samples in people with Bordetella Pertussis, Whooping Cough, run by Institut Pasteur at 14 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages Up to 15 years
Conditions the study is for
Bordetella Pertussis, Whooping Cough
What is being tested?
Nasopharyngeal swab and Blood samples
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
14 sitesFrance
Study dates
16 Nov 2023to 16 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Julie Toubiana, MD contact

+331 45 68 80 05

julie.toubiana@pasteur.fr

14 sites in 1 country

France14 sites, 14 recruiting

  • CHU de Bordeaux

    Bordeaux

    Emilie Pauquet, MD

    Not yet recruiting

  • Hôpital Louis Mourier

    Colombes

    Romain Basmaci, MD

    Recruiting

  • Centre hospitalier intercommunal de Créteil

    Créteil

    Fouad Madhi, MD

    Not yet recruiting

  • Hôpital Roger Salengo

    Lille

    François Dubos, MD

    Recruiting

  • Hospices Civils de Lyon

    Lyon

    Antoine Ouziel, MD

    Recruiting

  • Hôpital de la Timone Enfants, APHM

    Marseille

    Aurélie Morand, MD

    Recruiting

  • Hôpital Nord, APHM

    Marseille

    Philippe Minodier, MD

    Recruiting

  • CHU de Nantes

    Nantes

    David Malorey, MD

    Not yet recruiting

  • CHU Armand Trousseau

    Paris

    Mathie Lorrot, MD

    Recruiting

  • Hopital Necker

    Paris

    Julie Toubiana, MD

    Recruiting

  • Hôpital Robert Debré

    Paris

    Albert Faye, MD

    Not yet recruiting

  • CHU Rouen

    Rouen

    Didier Pinquier, MD

    Not yet recruiting

  • Réseau ACTIV

    Saint-Maur-des-Fossés

    Robert Cohen, MD

    Not yet recruiting

  • CHU de Toulouse

    Toulouse

    Camille Brehin, MD

    Recruiting

Other trials in France

About this study

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

Read more
  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.

Read the detailed description

The study design is characterized by 4 work packages:

  1. Collection of clinical data and biological samples (deep nasal swab, blood sample) from children with pertussis
  2. Construction and validation of a microbial panel of 200 genes of interest (involved in virulence and/or potential vaccine antigens) for transcriptomic analysis
  3. Transcriptomic study using the panel of interest of B. pertussis isolates from nasopharyngeal swabs preserved with an RNA stabilizer, using the Nanostring® technique
  4. Study of the immune response during pertussis
Being tested
Nasopharyngeal swab, Blood samples
Keywords
vaccination
Medical subject headings
Whooping Cough

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasopharyngeal swabBiological

    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.

  • Blood samplesBiological

    For hospitalized patients : 3 to 7.5 ml For ambulatory patients: Fingertip blood sampling

Study groups in NCT05897879
Study groupRoleWhat they receive
Children between 0 and 15 years with suspected pertussisOtherNot described
Receives: Biological: Nasopharyngeal swab; Biological: Blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 ;

    Measured: 3 years

  2. Measurement of plasma cytokine and chemokine concentrations by SIMOA digital ELISA

    To determine systemic and respiratory immune responses in children during pertussis.

    Measured: 3 years

  3. Phenotyping of immune cells by cytometry with a 20-color flow cytometry panel

    To determine systemic and respiratory immune responses in children during pertussis.

    Measured: 3 years

Secondary outcomes (3)

  1. 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

    Measured: 3 years

  2. Measurement of high expression level of Bp genes in all clinical forms of pertussis by Nanostring transcriptomic analysis of Bp isolates

    To identify new candidate Bp genes for a future protein vaccine

    Measured: 3 years

  3. 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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2023
  2. Study start16 Nov 2023
  3. Primary completion16 Nov 2025 (estimated)
  4. Study completion16 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05897879
Sponsor's protocol ID
2022-093
Other IDs
2023-A00004-41
Acronym
PERT-SEVEREII
Status last verified
May 2024
First submitted
22 May 2023
Last updated
24 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Nasopharyngeal swab and Blood samples in people with Bordetella Pertussis, Whooping Cough, run by Institut Pasteur at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julie Toubiana, MD (+331 45 68 80 05, julie.toubiana@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of expression level of Bp genes during infection by Nanostring transcriptomic analysis of Bp isolates from the nasopharynx of children with pertussis. (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05897879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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