Abscess, Peritonsillar Clinical Trial
— APAOfficial title:
Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess
| Verified date | January 2013 |
| Source | Nantes University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Observational |
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
| Status | Terminated |
| Enrollment | 711 |
| Est. completion date | July 2012 |
| Est. primary completion date | July 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | 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 | Nantes University Hospital | Nantes | Pays de Loire |
| France | Ambroise Paré Hospital | Paris | |
| France | Paris-Bichat-Hospital | Paris | |
| France | Paris-Cochin Hospital | Paris | |
| France | Paris-Lariboisière Hospital | Paris | |
| France | Paris-Tenon-Hospital | Paris | |
| France | Poitiers University Hospital | Poitiers | |
| France | Rennes University hospital | Rennes | |
| France | Toulouse University Hospital | Toulouse | |
| France | Tours University Hosipital | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Nantes University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | 2,5 years | Yes | |
| Secondary | 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 | 2,5 years | Yes |