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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00954031
Recruitment Status : Terminated
First Posted : August 6, 2009
Last Update Posted : January 31, 2013
Information provided by:
Nantes University Hospital

Brief Summary:

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 or disease
Abscess, Peritonsillar

Study Type : Observational
Estimated Enrollment : 711 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess
Study Start Date : March 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Abscess Antibiotics

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT00954031

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
Ambroise Paré Hospital
Paris, France
Paris, France
Paris-Cochin Hospital
Paris, France
Paris-Lariboisière Hospital
Paris, France
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
Principal Investigator: Gilles Potel, PhD Nantes University Hospital

Responsible Party: General director, Nantes University Hospital Identifier: NCT00954031     History of Changes
Other Study ID Numbers: BRD 08/9-W
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Peritonsillar Abscess
Pathologic Processes
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Inflammatory Agents
Anti-Infective Agents