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NCT04471493 Clinical Trial

Pediatric and Ambulatory Research in Infectious Diseases

Influenza Clinical Trial

— PARI  

Official title:
Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04471493
Other study ID # ACT0116
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 26, 2017
Est. completion date August 2, 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 [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 400000
Est. completion date August 2, 2030
Est. primary completion date June 27, 2030
Accepts healthy volunteers
Gender All
Age group 1 Day to 16 Years
Eligibility 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: - parental refusal

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France AFPA Créteil

Sponsors (6)
Lead Sponsor Collaborator
Association Clinique Thérapeutique Infantile du val de Marne AFPA (Association Française de Pédiatrie Ambulatoire), GlaxoSmithKline, Merck Sharp & Dohme LLC, Pfizer, Sanofi

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the number of infectious diseases proportion of children under 16 years, with infectious disease 5 years
Secondary 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 5 years
Secondary Evaluation of the antibiotic treatments Proportion of each antibiotic treatments according to the infectious diseases 5 years
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