Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study
NCT ID: NCT03237299
Last Updated: 2022-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
289 participants
OBSERVATIONAL
2019-07-10
2021-06-03
Brief Summary
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Detailed Description
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* Cases: children \< 18 years old hospitalized for peripharyngeal suppurations, diffuse cervical cellulitis or cervical adenophlegmon in participating Ear, Nose \& Throat (ENT) and pediatric departments.
* Controls: children \< 18 years old with pharyngitis but without infectious complications recruited by general practitioners (GPs) or by primary care pediatricians in private setting, matched to cases by age, date of infectious complication (index date), delay between the pharyngitis and the index date and, if possible, the referring physician.
Primary endpoint: Difference in the frequency of exposure to various factors among cases and controls during an exposure window going from the date of diagnosis of pharyngitis to day -0.5 of the index date of the complication.
Several exposure of interest will be compared between cases and controls. One specific main exposure of interest during a predefined window of exposure has been defined but will not be revealed to investigators to avoid selection bias. Several secondary exposure of interest were a priori defined but will not be revealed to investigators to avoid selection bias.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Cases
Cases: children with loco-regional complications of pharyngitis
Collection of data
Collection of data on clinical, bacteriological and computed tomography data concerning the case, which will be needed by the adjudication committee and for defining the index date.
Controls
Controls: children with pharyngitis but without infectious complications
No collection of data
The interviewer will note sociodemographic characteristics (age, weight, sex), symptoms and their evolution, and all drug intakes of the patient during the month before the index date.
Interventions
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Collection of data
Collection of data on clinical, bacteriological and computed tomography data concerning the case, which will be needed by the adjudication committee and for defining the index date.
No collection of data
The interviewer will note sociodemographic characteristics (age, weight, sex), symptoms and their evolution, and all drug intakes of the patient during the month before the index date.
Eligibility Criteria
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Inclusion Criteria
Controls: children \< 18 years old with pharyngitis but without infectious complications recruited by general practitioners (GPs) or by primary care pediatricians in private setting, matched to cases by age, date of infectious complication (index date), delay between the pharyngitis and the index date and, if possible, the referring physician.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Martin CHALUMEAU, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Hôpital Necker Enfants Malades - AP-HP
Paris, , France
Countries
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Other Identifiers
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NI14034J
Identifier Type: -
Identifier Source: org_study_id
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