Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04807712 |
| Other study ID # |
ACT0606 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2001 |
| Est. completion date |
January 1, 2030 |
Study information
| Verified date |
January 2024 |
| Source |
Association Clinique Thérapeutique Infantile du val de Marne |
| Contact |
Corinne Levy, MD |
| Phone |
0033148850404 |
| Email |
corinne.levy[@]activ-france.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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).
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
