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RecruitingNCT04471493PARIUpdated Feb 8, 2024

Pediatric and Ambulatory Research in Infectious Diseases

An observational study in Otitis, Bronchiolitis and Influenza, sponsored by Association Clinique Thérapeutique Infantile du val de Marne. Recruiting at 1 site in France. Open to participants aged 1 Day to 16 Years. Per ClinicalTrials.gov, last updated 2024-02-08.

Sponsored by Association Clinique Thérapeutique Infantile du val de Marne · Observational

From the registry’s dates

  • Started Jun 2017; still recruiting 9 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
400,000
Ages
1 Day to 16 Years
Sex
All
01

Study summary

Many ambulatory networks are mainly based on diagnoses made by first-line physicians not specifically trained to join the network. Here we aim to set up a surveillance network on pediatric infectious diseases with an investment in teaching with specific trainings of participating pediatricians, increasing in use of point of care tests, and automated data extraction from the computers of the pediatricians.

Read the detailed description

107 pediatricians among the 1400 members of the French ambulatory pediatric association, AFPA (Association Française de Pédiatrie Ambulatoire) were involved in this survey.To belong to the PARI network, pediatricians have to use the same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France) for electronic medical record of children. The pediatricians were trained to the use of point of care tests and to the infectious diagnoses (otitis, pharyngitis, varicella, bronchiolitis, influenza, pneumonia, etc..). The study population consisted of all children under 16 years of age from the patient population for which an infectious disease was diagnosed.

02

Conditions studied

  • Otitis
  • Bronchiolitis
  • Influenza
  • Pharyngitis
  • Varicella
  • Pneumonia
  • Gastroenteritis

Keywords

  • Vaccination
  • Antibiotic treatment
  • Point of care test
  • automated data extraction
  • network
03

In context

Otitis

80 studies on the registry are indexed under Otitis; 10 are open to participants now.

This study's planned enrollment of 400,000 is above the median of 177 across 26 observational studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Association Clinique Thérapeutique Infantile du val de Marne is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Day to 16 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Children under 16 years with infectious disease

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children under 16 years of age with at least one infectious disease among:
  • pharyngitis
  • otitis
  • pneumonia
  • influenza
  • bronchiolitisz
  • varicella
  • gastroenteritis
  • enterovirus disease
  • bordetella pertussis disease
  • using the same same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France)

Exclusion criteria

Exclusion Criteria:

  • parental refusal
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Evaluation of the number of infectious diseases

    proportion of children under 16 years, with infectious disease

    Time frame: 5 years

Secondary outcomes

  1. Evaluation of the use of point of care tests

    Proportion of use of point of care tests and positivity rate according to the infectious diseases

    Time frame: 5 years

  2. Evaluation of the antibiotic treatments

    Proportion of each antibiotic treatments according to the infectious diseases

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Cohen R, Bechet S, Gelbert N, Frandji B, Vie Le Sage F, Thiebault G, Kochert F, Cahn-Sellem F, Werner A, Ouldali N, Levy C. New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era. Pediatr Infect Dis J. 2021 Jul 1;40(7):674-680. doi: 10.1097/INF.0000000000003116. PubMed 33657594 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2017 (actual). Primary completion is estimated for Jun 2030, 156 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2020
First posted
Jul 15, 2020
StartActual
Jun 26, 2017
Primary completionEst.
Jun 27, 2030
CompletionEst.
Aug 2, 2030
Last update
Feb 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04471493
Lead sponsor
Association Clinique Thérapeutique Infantile du val de Marne
Collaborators
AFPA (Association Française de Pédiatrie Ambulatoire), GlaxoSmithKline, Sanofi, Pfizer, Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 15, 2020
Start date
Jun 26, 2017
Primary completion
Jun 27, 2030 (estimated)
Completion
Aug 2, 2030 (estimated)
Last update
Feb 8, 2024

Study contacts

Corinne LEVY, MD
Contact
corinne.levy@activ-france.fr
0033148850404
Stéphane Béchet, MSc
Contact
stephane.bechet@activ-france.fr
0033148850404
Robert Cohen
study director · Association Clinique et Thérapeutique Infantile du Val de Marne

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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