Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study

NCT ID: NCT03237299

Last Updated: 2022-09-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

289 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-10

Study Completion Date

2021-06-03

Brief Summary

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To study the association between several exposures of interest and the occurrence of infectious loco-regional complications of pharyngitis in children.

Detailed Description

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Investigators will include in the study (after agreement of child and parents):

* 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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Pharyngitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Cases: children with loco-regional complications of pharyngitis

Collection of data

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

Children (cases or controls) with chronic renal failure, hemophilia, chronic thrombocytopenia or immunosuppression (constitutional or iatrogenic) at the time of pharyngitis
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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France

Other Identifiers

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NI14034J

Identifier Type: -

Identifier Source: org_study_id

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