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

This study has been terminated.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00954031
First received: August 5, 2009
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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:

  1. - Analyze the implementation of a rapid diagnostic test and its result on the occurrence of an ABS
  2. - 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
  3. - Describe the microbial flora could puncture of patients hospitalized for APA

Condition
Abscess, Peritonsillar

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 711
Study Start Date: March 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00954031

Locations
France
Nantes University Hospital
Nantes, Pays de Loire, France, 44200
Angers university Hospital
Angers, France
Caen universty Hospital
Caen, France
Clermont Ferrand University Hospital
Clermont Ferrand, France
Grenoble University Hospital
Grenoble, France
Lille University Hospital
Lille, France
Paris-Cochin Hospital
Paris, France
Paris-Tenon-Hospital
Paris, France
Paris-Bichat-Hospital
Paris, France
Ambroise Paré Hospital
Paris, France
Paris-Lariboisière Hospital
Paris, France
Poitiers University Hospital
Poitiers, France
Rennes University hospital
Rennes, France
Toulouse University Hospital
Toulouse, France
Tours University Hosipital
Tours, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Gilles Potel, PhD Nantes University Hospital
  More Information

No publications provided

Responsible Party: General director, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00954031     History of Changes
Other Study ID Numbers: BRD 08/9-W
Study First Received: August 5, 2009
Last Updated: January 30, 2013
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Abscess
Peritonsillar Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Tonsillitis
Pharyngitis
Pharyngeal Diseases
 Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 22, 2013