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

Completed

• Conditions: Pharyngitis
• Interventions: Other: Collection of data; Other: No collection of data

• Registration Number: NCT03237299
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-07-31
• Study First Posted: 2017-08-02
• Study Start: 2019-07-10
• Primary Completion: 2021-06-03
• Study Completion: 2021-06-03
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 289

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Frequency of exposure of interest	from the date of diagnosis of pharyngitis up to 6 weeks

Secondary Outcome Measures

Name	Time	Method
Magnitude of the exposure of interest	from the date of diagnosis of pharyngitis up to 6 weeks

Trial Locations

Locations (1)

Hôpital Necker Enfants Malades - AP-HP; 🇫🇷 Paris, France