- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04471493
Pediatric and Ambulatory Research in Infectious Diseases (PARI)
February 7, 2024 updated by: Association Clinique Thérapeutique Infantile du val de Marne
Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study
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.
Study Overview
Status
Recruiting
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.
Study Type
Observational
Enrollment (Estimated)
400000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Corinne Levy, MD
- Phone Number: 0033148850404
- Email: corinne.levy@activ-france.fr
Study Contact Backup
- Name: Stéphane Béchet, MSc
- Phone Number: 0033148850404
- Email: stephane.bechet@activ-france.fr
Study Locations
-
-
-
Créteil, France
- Recruiting
- AFPA
-
Contact:
- Corinne Levy, MD
- Phone Number: 0033148850404
- Email: corinne.levy@activ-france.fr
-
Contact:
- Stéphane Béchet, MSc
- Phone Number: 0033148850404
- Email: stephane.bechet@activ-france.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 16 years (Child)
Accepts Healthy Volunteers
N/A
Sampling Method
Probability Sample
Study Population
Children under 16 years with infectious disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the number of infectious diseases
Time Frame: 5 years
|
proportion of children under 16 years, with infectious disease
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the use of point of care tests
Time Frame: 5 years
|
Proportion of use of point of care tests and positivity rate according to the infectious diseases
|
5 years
|
Evaluation of the antibiotic treatments
Time Frame: 5 years
|
Proportion of each antibiotic treatments according to the infectious diseases
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Robert Cohen, Association Clinique et Thérapeutique Infantile du Val de Marne
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2017
Primary Completion (Estimated)
June 27, 2030
Study Completion (Estimated)
August 2, 2030
Study Registration Dates
First Submitted
July 8, 2020
First Submitted That Met QC Criteria
July 10, 2020
First Posted (Actual)
July 15, 2020
Study Record Updates
Last Update Posted (Actual)
February 8, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Gastrointestinal Diseases
- Bronchial Diseases
- Pharyngeal Diseases
- Stomatognathic Diseases
- Otorhinolaryngologic Diseases
- Lung Diseases, Obstructive
- Bronchitis
- Infections
- Communicable Diseases
- Gastroenteritis
- Bronchiolitis
- Pharyngitis
Other Study ID Numbers
- ACT0116
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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