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
| Type | Name | Description |
|---|---|---|
| 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. |
| OTHER | 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. |
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.