Pediatric Pertussis in Ambulatory Settings

NCT04807712 | Recruiting DMC

• 1 other identifier: ACT0606
• Study Type: observational
• Target: 898
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pertussis/Whooping Cough; Children, Only; Ambulatory

Keywords

Pertussis; surveillance; pertussis acellular vaccine

Outcome Measures

Primary Outcomes (1)

• Duration of pertussis vaccines protection

  Evaluate the duration of protection of the Ca vaccines

  at inclusion

Secondary Outcomes (1)

• Clinical characteristics of pertussis

  at inclusion

Interventions

non interventional study OTHER

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

children under 18 years with suspected pertussis diagnosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Association Clinique Thérapeutique Infantile du val de Marne: lead
• GlaxoSmithKline: collaborator
• Sanofi: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

ACTIV

Créteil, 94000, France

RECRUITING

Related Links

• Whooping cough surveillance in France in pediatric private practice in 2006-2015
• Pertussis surveillance in private pediatric practices, France, 2002-2006
• Guidelines for diagnosis of whooping cough

MeSH Terms

Conditions

Whooping Cough

Condition Hierarchy (Ancestors)

Bordetella Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

Study Officials

• Nicole Guiso

  Institut Pasteur

  STUDY DIRECTOR

Central Study Contacts

Corinne Levy, MD

CONTACT

0033148850404; corinne.levy@activ-france.fr

Stéphane Béchet, MsC

CONTACT

0033148850404; stephane.bechet@activ-france.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 19, 2021
• Study Start: May 30, 2001
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

FR (1)