Pediatric and Ambulatory Research in Infectious Diseases

NCT04471493 | Recruiting DMC

• 1 other identifier: ACT0116
• Study Type: observational
• Target: 400,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Otitis; Bronchiolitis; Influenza; Pharyngitis; Varicella; Pneumonia; Gastroenteritis

Keywords

Vaccination; Antibiotic treatment; Point of care test; automated data extraction; network

Outcome Measures

Primary Outcomes (1)

• Evaluation of the number of infectious diseases

  proportion of children under 16 years, with infectious disease

  5 years

Secondary Outcomes (2)

• Evaluation of the use of point of care tests

  5 years

• Evaluation of the antibiotic treatments

  5 years

Eligibility Criteria

• Age: 1 Day - 16 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children under 16 years with infectious disease

You may qualify if:

• 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)

You may not qualify if:

• parental refusal

Sponsors & Collaborators

• Association Clinique Thérapeutique Infantile du val de Marne: lead
• AFPA (Association Française de Pédiatrie Ambulatoire): collaborator
• GlaxoSmithKline: collaborator
• Sanofi: collaborator
• Pfizer: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

AFPA

Créteil, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 33657594 DERIVED

Related Links

• New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital Era
• Trends in pediatric ambulatory community acquired infections before and during COVID-19 pandemic: A prospective multicentric surveillance study in France

MeSH Terms

Conditions

Otitis; Bronchiolitis; Influenza, Human; Pharyngitis; Chickenpox; Pneumonia; Gastroenteritis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robert Cohen

  Association Clinique et Thérapeutique Infantile du Val de Marne

  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
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 15, 2020
• Study Start: June 26, 2017
• Primary Completion (Estimated): June 27, 2030
• Study Completion (Estimated): August 2, 2030
• Last Updated: February 8, 2024

Record last verified: 2024-01

Locations

FR (1)