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NCT Number: NCT04807712

Pediatric Pertussis in Ambulatory Settings

Since 2002, Whooping cough surveillance in pediatric private practice has been set up in France. The results of the first years, 2002-2006, have confirmed the effectiveness of the Pertussis whole-cell (Pw) vaccine and in particular the duration of protection of 9/10 years. After evaluating cases in children vaccinated with Pw vaccines, the study aims today to analyze cases in children vaccinated with Pertussis acellular (Pa) vaccines used since 2002/2003 and to assess, on an outpatient basis, the impact of new vaccine recommendations in France (in 2013, introduction of a 2 + 1 schedule - 8 weeks, 4 months and a 11-month recall - and a 6-year recall, and in 2014, update in the recommendations of exams to be prescribed based on the child's age and vaccination status).

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Key information

Conditions

Pertussis/Whooping Cough Ambulatory Bacterial Infections Bacterial Infections and Mycoses Bordetella Infections Children, Only Gram-Negative Bacterial Infections Infections Respiratory Tract Diseases Respiratory Tract Infections Whooping Cough

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

The whooping cough surveillance objectives are :

  • to follow the duration of protection of the Ca vaccines in the context of modifications of the vaccine recommendations
  • to describe the clinical characteristics of a population vaccinated with several boosters
  • to adapt complementary examinations for diagnostic purposes (culture, PCR, serology) according to the evolution of scientific knowledge
  • to monitor B. parapertussis infections
  • to train laboratories with nasopharyngeal aspiration
  • to monitor the evolution of the bacterial species All children aged 0-18 years, in whom the diagnosis of pertussis is mentioned and for which a biological check-up is requested, are included, except asymptomatic children with confirmed family case.

In case of suspected pertussis, real-time PCR and / or culture and / or (rarely) serology is / are still prescribed to the patient and / or his entourage.

Selected Pediatricians from the ACTIV group and the AFPA working in an outpatient clinic, located in different places in France, are participating in this network since 2001. The clinical evolution and the results of the examinations are transcribed on a case report form. The data are collected, firstly, during the visit where the diagnosis of whooping cough is suspected and a biological assessment requested (patient's medical history, clinical data, vaccination status and dates, as well as the search for a contaminated/contaminator) and secondly during the follow-up visit (results of the biological check-up and diagnosis, antibiotics potentially prescribed, and supplement data of the entourage, except in case of diagnosis of pertussis not retained).

All evaluations made by the pediatricians are regularly reviewed during meetings, and final diagnoses used are:

  • biological pertussis
  • epidemiological pertussis
  • not evaluable
  • lost of follow up
  • no whooping cough

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All children under 18 years old with a pertussis diagnosis is suspected and a biological exam is requested

Exclusion criteria

  • children without symptoms with a household confirmed case
  • cases for which the pertussis diagnosis was not suspected by the pediatrician

Treatment and study plan

Non interventional study

Other

Primary outcomes

  1. Duration of pertussis vaccines protection

    Time frame: at inclusion

    Evaluate the duration of protection of the Ca vaccines

Secondary outcomes

  1. Clinical characteristics of pertussis

    Time frame: at inclusion

    Describe the clinical characteristics of a population vaccinated

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne Levy, MD

CONTACT

[email protected]

0033148850404

Stéphane Béchet, MsC

CONTACT

[email protected]

0033148850404

Sponsors and collaborators

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Other

Collaborators

  • GlaxoSmithKline
  • Merck Sharp & Dohme LLC
  • Sanofi

Registry information

Official study title

National Surveillance of Pediatric Pertussis in Ambulatory Settings

Acronym: ACTIVCOQ

Important dates

Study start
2001
Primary completion
2030
Study completion
2030
First posted
Mar 19, 2021
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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