Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study (CAPE)
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|ClinicalTrials.gov Identifier: NCT03237299|
Recruitment Status : Suspended (COVID-19)
First Posted : August 2, 2017
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment|
|Pharyngitis||Other: Collection of data Other: No collection of data|
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 Type :||Observational|
|Estimated Enrollment :||525 participants|
|Official Title:||Loco-regional Complications of Pharyngitis in Children: a National Case-Control Study|
|Actual Study Start Date :||July 10, 2019|
|Estimated Primary Completion Date :||August 10, 2021|
|Estimated Study Completion Date :||October 10, 2021|
Cases: children with loco-regional complications of pharyngitis
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.
Controls: children with pharyngitis but without infectious complications
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.
- Frequency of exposure of interest [ Time Frame: from the date of diagnosis of pharyngitis up to 6 weeks ]
- Magnitude of the exposure of interest [ Time Frame: from the date of diagnosis of pharyngitis up to 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237299
|Hôpital Necker Enfants Malades - AP-HP|
|Paris, France, 75015|
|Principal Investigator:||Martin CHALUMEAU, MD, PhD||Assistance Publique - Hôpitaux de Paris|