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

Pharyngitis Clinical Trial

— CAPE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237299
• Other study ID #: NI14034J
• Status: Completed
• Start date: July 10, 2019
• Est. completion date: June 3, 2021

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: June 3, 2021
• Est. primary completion date: June 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Hôpital Necker Enfants Malades - AP-HP	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of exposure of interest		from the date of diagnosis of pharyngitis up to 6 weeks
Secondary	Magnitude of the exposure of interest		from the date of diagnosis of pharyngitis up to 6 weeks