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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

August 5, 2009
January 30, 2013
March 2009
July 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00954031 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess
Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess

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
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Patients, adult or child, including the diagnosis of APA was made, after consulting their physician
Abscess, Peritonsillar
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
711
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00954031
BRD 08/9-W
No
General director, Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Gilles Potel, PhD Nantes University Hospital
Nantes University Hospital
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP