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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
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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

Condition or disease Intervention/treatment
Pharyngitis Other: Collection of data Other: No collection of data

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.

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Study Type : Observational
Estimated Enrollment : 525 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

Group/Cohort Intervention/treatment
Cases
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
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.




Primary Outcome Measures :
  1. Frequency of exposure of interest [ Time Frame: from the date of diagnosis of pharyngitis up to 6 weeks ]

Secondary Outcome Measures :
  1. Magnitude of the exposure of interest [ Time Frame: from the date of diagnosis of pharyngitis up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   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
Criteria

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


Information from the National Library of Medicine

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


Locations
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France
Hôpital Necker Enfants Malades - AP-HP
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Martin CHALUMEAU, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03237299    
Other Study ID Numbers: NI14034J
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: April 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Pharyngitis
case-control study
loco-regional complications of pharyngitis
Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases