Clinical trial NCT03237299: Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study
Official title: Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharyngitis
Keywords: Pharyngitis
case-control study
loco-regional complications of pharyngitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-08-02
Enrollment: 289
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases: participating Ear, Nose \& Throat (ENT) and pediatric departments Controls: recruited ''in office settings'' by general practitioners (GPs) or by primary care paediatricians

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Frequency of exposure of interest
timeFrame: from the date of diagnosis of pharyngitis up to 6 weeks
Secondary outcomes:
measure: Magnitude of the exposure of interest
timeFrame: from the date of diagnosis of pharyngitis up to 6 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker Enfants Malades - AP-HP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Martin CHALUMEAU, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: