Pediatric Pertussis in Ambulatory Settings (ACTIVCOQ)

February 7, 2024 updated by: Association Clinique Thérapeutique Infantile du val de Marne

National Surveillance of 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Estimated)

898

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

children under 18 years with suspected pertussis diagnosis

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of pertussis vaccines protection
Time Frame: at inclusion
Evaluate the duration of protection of the Ca vaccines
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical characteristics of pertussis
Time Frame: at inclusion
Describe the clinical characteristics of a population vaccinated
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Clinique Thérapeutique Infantile du val de Marne

Collaborators

Sanofi
GlaxoSmithKline
Merck Sharp & Dohme LLC

Investigators

  • Study Director: Nicole Guiso, Institut Pasteur

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2001

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT0606

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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