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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03237299
Acronym
CAPE
Enrollment
289
Registered
2017-08-02
Start date
2019-07-10
Completion date
2021-06-03
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharyngitis

Keywords

Pharyngitis, case-control study, loco-regional complications of pharyngitis

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.

Interventions

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.

OTHERNo 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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER
URC-CIC Paris Descartes Necker Cochin
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Frequency of exposure of interestfrom the date of diagnosis of pharyngitis up to 6 weeks

Secondary

MeasureTime frame
Magnitude of the exposure of interestfrom the date of diagnosis of pharyngitis up to 6 weeks

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMartin CHALUMEAU, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026