Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess (APA)

January 30, 2013 updated by: Nantes University Hospital

Analyze in children and adults, risk factors in the onset of the APA. The main hypothesis focuses on the use of anti-inflammatory in the context of pharyngitis or sore throat before the symptoms of ABS. Secondary objectives:

- Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS
- Measure the frequency of prescription and describe the reasons for not prescribing an antibiotic for patients who consulted for a sore throat and having developed a PLA
- Describe the microbial flora could puncture of patients hospitalized for APA

Study Overview

Status

Terminated

Conditions

Abscess, Peritonsillar

Study Type

Observational

Enrollment (Anticipated)

711

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Angers, France
    - Angers University Hospital
  - Caen, France
    - Caen universty Hospital
  - Clermont Ferrand, France
    - Clermont Ferrand University Hospital
  - Grenoble, France
    - Grenoble University Hospital
  - Lille, France
    - Lille University Hospital
  - Paris, France
    - Ambroise Paré Hospital
  - Paris, France
    - Paris-Bichat-Hospital
  - Paris, France
    - Paris-Cochin Hospital
  - Paris, France
    - Paris-Lariboisière Hospital
  - Paris, France
    - Paris-Tenon-Hospital
  - Poitiers, France
    - Poitiers University Hospital
  - Rennes, France
    - Rennes University Hospital
  - Toulouse, France
    - Toulouse University Hospital
  - Tours, France
    - Tours University Hosipital
- Pays de Loire
  - Nantes, Pays de Loire, France, 44200
    - Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, adult or child, including the diagnosis of APA was made, after consulting their physician

Description

Inclusion Criteria:

clinical existence of a PLA (phlegmon), validated by a senior ENT, usually (but not necessarily) following a request by an emergency. The visible appearance to the merits throat must justify puncture. Cases will be included whether or not they had consulted for a "sore throat" in the 10 days preceding the date of diagnosis

Exclusion Criteria:

Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
case hospitalized patients, adult or child, including the diagnosis of APA was made, after consulting their physician.
The control group Two patients witnesses will be matched to each case: Chronological criterion: consultation for a "sore throat" 10 days (± 3 days) before the date of hospitalization of cases, between 13 and J-J-7. Age criteria: year of birth ± 5 years Geographical criteria: living in the same department, failing in an adjacent Department Social criteria: beneficiary or otherwise of the CMU, to avoid a selection bias leading social most frequently at the onset of the APA

Group / Cohort

case

hospitalized patients, adult or child, including the diagnosis of APA was made, after consulting their physician.

The control group

Two patients witnesses will be matched to each case:

Chronological criterion: consultation for a "sore throat" 10 days (± 3 days) before the date of hospitalization of cases, between 13 and J-J-7.

Age criteria: year of birth ± 5 years Geographical criteria: living in the same department, failing in an adjacent Department Social criteria: beneficiary or otherwise of the CMU, to avoid a selection bias leading social most frequently at the onset of the APA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The principal judgement criterion of the study is the positive diagnosis of an APA. The explanatory variables to meet the main objective is the drug exposure (anti-inflammatory) Time Frame: 2,5 years	2,5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The explanatory variables to meet the secondary objectives are: - The creation of a TDR - The prescription of antibiotics - The diagnosis of angina Strep Group A - The identification of a group A streptococcus in t Time Frame: 2,5 years	2,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

Principal Investigator: Gilles Potel, PhD, Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)