Pediatric Pertussis in Ambulatory Settings

NCT ID: NCT04807712

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

898 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-05-30

Study Completion Date

2030-01-01

Brief Summary

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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).

Detailed Description

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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

Conditions

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Pertussis/Whooping Cough Children, Only Ambulatory

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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non interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Sanofi

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Association Clinique Thérapeutique Infantile du val de Marne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Guiso

Role: STUDY_DIRECTOR

Institut Pasteur

Locations

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ACTIV

Créteil, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Corinne Levy, MD

Role: CONTACT

0033148850404

Stéphane Béchet, MsC

Role: CONTACT

0033148850404

Facility Contacts

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Corinne Levy, MD

Role: primary

0033148850404

Stéphane Béchet, MSc

Role: backup

0033148850404

Related Links

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https://pubmed.ncbi.nlm.nih.gov/28974408/

Whooping cough surveillance in France in pediatric private practice in 2006-2015

https://pubmed.ncbi.nlm.nih.gov/18598649/

Pertussis surveillance in private pediatric practices, France, 2002-2006

https://pubmed.ncbi.nlm.nih.gov/14550985/

Guidelines for diagnosis of whooping cough

Other Identifiers

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ACT0606

Identifier Type: -

Identifier Source: org_study_id

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