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

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Pharyngitis

Treatments

Other: No collection of data
Other: Collection of data

Study type

Observational

Funder types

Other

Identifiers

NCT03237299
NI14034J

Details and patient eligibility

About

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

Full description

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.

Enrollment

289 patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

289 participants in 2 patient groups

Cases
Description:
Cases: children with loco-regional complications of pharyngitis
Treatment:
Other: Collection of data
Controls
Description:
Controls: children with pharyngitis but without infectious complications
Treatment:
Other: No collection of data

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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