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

NCT03237299 | Completed

• 1 other identifier: NI14034J
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pharyngitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Frequency of exposure of interest

  from the date of diagnosis of pharyngitis up to 6 weeks

Secondary Outcomes (1)

• Magnitude of the exposure of interest

  from the date of diagnosis of pharyngitis up to 6 weeks

Study Arms (2)

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

Collection of data OTHER

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.

Cases

No collection of data OTHER

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.

Controls

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Hôpital Necker Enfants Malades - AP-HP

Paris, Paris, 75015, France

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Martin CHALUMEAU, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: July 10, 2019
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)