Pertussis/Whooping CoughACTIVCOQNCT04807712
Pediatric Pertussis in Ambulatory Settings
An observational study of Pertussis/Whooping Cough and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Pertussis/Whooping Cough, Children, Only, Ambulatory
- What is being tested?
- non interventional study
- How many people
- 898 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2001to 1 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- Child, Adult
Study population: children under 18 years with suspected pertussis diagnosis
Who may be able to join
- All children under 18 years old with a pertussis diagnosis is suspected and a biological exam is requested
Who cannot join
- children without symptoms with a household confirmed case
- cases for which the pertussis diagnosis was not suspected by the pediatrician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
ACTIV
Créteil, 94000
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: 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).
Read the 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
- Conditions
- Pertussis/Whooping Cough, Children, Only, Ambulatory
- Being tested
- non interventional study
- Keywords
- Pertussis, surveillance, pertussis acellular vaccine
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional studyOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of pertussis vaccines protection
Evaluate the duration of protection of the Ca vaccines
Measured: at inclusion
Secondary outcomes (1)
Clinical characteristics of pertussis
Describe the clinical characteristics of a population vaccinated
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start30 May 2001
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pertussis/Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 898 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Sanofi, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Nicole Guiso, Study director, Institut Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807712
- Sponsor's protocol ID
- ACT0606
- Acronym
- ACTIVCOQ
- Status last verified
- Jan 2024
- First submitted
- 18 Mar 2021
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Surveillance of Pediatric Pertussis in Ambulatory Settings
- ClinicalTrials.gov ID
- NCT04807712
- Acronym / sponsor ID
- ACTIVCOQ / ACT0606
- Conditions
- Pertussis/Whooping Cough, Children, Only, Ambulatory
- Keywords
- Pertussis, surveillance, pertussis acellular vaccine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 898 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Sanofi, Merck Sharp & Dohme LLC
- Study start
- 30 May 2001 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- children under 18 years with suspected pertussis diagnosis
Key inclusion criteria (1 listed)
- All children under 18 years old with a pertussis diagnosis is suspected and a biological exam is requested
Key exclusion criteria (2 listed)
- children without symptoms with a household confirmed case
- cases for which the pertussis diagnosis was not suspected by the pediatrician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non interventional study | Other | – |
Primary outcome
Duration of pertussis vaccines protection
Time frame: at inclusion
Evaluate the duration of protection of the Ca vaccines
1 secondary outcome
Clinical characteristics of pertussis
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Whooping cough surveillance in France in pediatric private practice in 2006-2015Link provided by the sponsor.
- Pertussis surveillance in private pediatric practices, France, 2002-2006Link provided by the sponsor.
- Guidelines for diagnosis of whooping coughLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Guiso study director
Institut Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pertussis/Whooping Cough and Children, Only, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne Levy, MD (0033148850404, corinne.levy@activ-france.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of pertussis vaccines protection (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.