OtitisPARINCT04471493
Pediatric and Ambulatory Research in Infectious Diseases
An observational study of Otitis and Bronchiolitis, run by Association Clinique Thérapeutique Infantile du val de Marne at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 1 day to 16 years
- Conditions the study is for
- Otitis, Bronchiolitis, Influenza
- How many people
- 400,000 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2017to 2 Aug 2030
- How long will I take part?
- 5 Years
- 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 16 years
- All sexes
- Child
Study population: Children under 16 years with infectious disease
Who may be able to join
- Children under 16 years of age with at least one infectious disease among:
- pharyngitis
- otitis
- pneumonia
- influenza
- bronchiolitisz
Show all 11Show fewer
- varicella
- gastroenteritis
- enterovirus disease
- bordetella pertussis disease
- using the same same software, Axi5-Infansoft (developed by CompuGroup Medical, Nanterre, France)
Who cannot join
- parental refusal
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
AFPA
Créteil
Corinne Levy, MD, 0033148850404, corinne.levy@activ-france.fr
Stéphane Béchet, MSc, 0033148850404, stephane.bechet@activ-france.fr
About this study
Official title: 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.
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.
- Conditions
- Otitis, Bronchiolitis, Influenza, Pharyngitis, Varicella, Pneumonia
- Keywords
- Vaccination, Antibiotic treatment, Point of care test, automated data extraction, network
- Medical subject headings
- Otitis, Bronchiolitis, Influenza, Human, Pharyngitis, Chickenpox, Pneumonia, Gastroenteritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the number of infectious diseases
proportion of children under 16 years, with infectious disease
Measured: 5 years
Secondary outcomes (2)
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
Measured: 5 years
Evaluation of the antibiotic treatments
Proportion of each antibiotic treatments according to the infectious diseases
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start26 Jun 2017
- Primary completion27 Jun 2030 (estimated)
- Study completion2 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OtitisStudies 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
- 400,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de Marne
- Sponsor type
- University, hospital or other
- Collaborators
- AFPA (Association Française de Pédiatrie Ambulatoire), GlaxoSmithKline, Sanofi, Pfizer, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Robert Cohen, Study director, Association Clinique et Thérapeutique Infantile du Val de Marne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471493
- Sponsor's protocol ID
- ACT0116
- Acronym
- PARI
- Status last verified
- Jan 2024
- First submitted
- 8 Jul 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cohen R, Ouldali N, Bechet S, Gelbert N, Le Sage FV, Werner A, Levy C. Disruption of Epidemic Patterns in Community-Acquired Respiratory Infections Post-Covid-19 in France: A 5-Year Analysis Using the French Pediatric and Ambulatory Research of Infectious Diseases Network. Pediatr Infect Dis J. 2026 Mar 1;45(3):e75-e78. doi: 10.1097/INF.0000000000005033. Epub 2025 Nov 3.
PubMed 41251685Cohen 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
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
- Real Time Surveillance of Pediatric Infectious Diseases in French Ambulatory Care: PARI Study
- ClinicalTrials.gov ID
- NCT04471493
- Acronym / sponsor ID
- PARI / ACT0116
- Conditions
- Otitis, Bronchiolitis, Influenza, Pharyngitis, Varicella, Pneumonia
- Keywords
- Vaccination, Antibiotic treatment, Point of care test, automated data extraction, network
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400,000 participants (estimated)
- Lead sponsor
- Association Clinique Thérapeutique Infantile du val de MarneUniversity, hospital or other
- Collaborators
- AFPA (Association Française de Pédiatrie Ambulatoire), GlaxoSmithKline, Sanofi, Pfizer, Merck Sharp & Dohme LLC
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 27 Jun 2030 (estimated)
- Study completion
- 2 Aug 2030 (estimated)
- First posted
- 15 Jul 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Age groups
- Child
- Study population
- Children under 16 years with infectious disease
Key inclusion criteria (11 listed)
- Children under 16 years of age with at least one infectious disease among:
- pharyngitis
- otitis
- pneumonia
- influenza
Key exclusion criteria (1 listed)
- parental refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the number of infectious diseases
Time frame: 5 years
proportion of children under 16 years, with infectious disease
2 secondary outcomes
Evaluation of the use of point of care tests
Time frame: 5 years
Evaluation of the antibiotic treatments
Time frame: 5 years
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.
- Derived from this study: PubMed 41251685Cohen R, Ouldali N, Bechet S, Gelbert N, Le Sage FV, Werner A, Levy C. Disruption of Epidemic Patterns in Community-Acquired Respiratory Infections Post-Covid-19 in France: A 5-Year Analysis Using the French Pediatric and Ambulatory Research of Infectious Diseases Network. Pediatr Infect Dis J. 2026 Mar 1;45(3):e75-e78. doi: 10.1097/INF.0000000000005033. Epub 2025 Nov 3.
- Derived from this study: PubMed 33657594Cohen 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.
- New Approach to the Surveillance of Pediatric Infectious Diseases From Ambulatory Pediatricians in the Digital EraLink provided by the sponsor.
- Trends in pediatric ambulatory community acquired infections before and during COVID-19 pandemic: A prospective multicentric surveillance study in FranceLink 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.
Robert Cohen study director
Association Clinique et Thérapeutique Infantile du Val de Marne
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 Otitis and Bronchiolitis, 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 11 inclusion and 1 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?
Evaluation of the number of infectious diseases (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04471493, which also lists 2 linked publications.
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.