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CompletedNCT03237299CAPEUpdated Mar 30, 2026

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

An observational study in Pharyngitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
289
Ages
Up to 18 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pharyngitis

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Keywords

  • Pharyngitis
  • case-control study
  • loco-regional complications of pharyngitis
03

Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Cases: participating Ear, Nose \& Throat (ENT) and pediatric departments Controls: recruited ''in office settings'' by general practitioners (GPs) or by primary care paediatricians

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

Exclusion Criteria:

Children (cases or controls) with chronic renal failure, hemophilia, chronic thrombocytopenia or immunosuppression (constitutional or iatrogenic) at the time of pharyngitis

04

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
289 participants (actual)
Patient registry
No

Groups and cohorts

  • Cases

    Cases: children with loco-regional complications of pharyngitis

    Other: Collection of data

  • Controls

    Controls: children with pharyngitis but without infectious complications

    Other: No collection of data

Interventions

  • OtherCollection 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.

  • 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.

05

What researchers measure

Primary outcomes

  1. Frequency of exposure of interest

    Time frame: from the date of diagnosis of pharyngitis up to 6 weeks

Secondary outcomes

  1. Magnitude of the exposure of interest

    Time frame: from the date of diagnosis of pharyngitis up to 6 weeks

06

Study locations

1 site
  • Hôpital Necker Enfants Malades - AP-HP
    Paris, Paris 75015, France
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03237299
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Aug 2, 2017
Start date
Jul 10, 2019
Primary completion
Jun 3, 2021
Completion
Jun 3, 2021
Last update
Mar 30, 2026

Study contacts

Martin CHALUMEAU, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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