Clinical Trials Directory

Trials / Completed

CompletedNCT03237299

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

Status
Completed
Phase
Study type
Observational
Enrollment
289 (actual)
Sponsor
Assistance Publique - Hôpitaux de Paris · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERCollection of dataCollection 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.
OTHERNo collection of dataThe 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.

Timeline

Start date
2019-07-10
Primary completion
2021-06-03
Completion
2021-06-03
First posted
2017-08-02
Last updated
2026-03-30

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03237299. Inclusion in this directory is not an endorsement.