Abscess, PeritonsillarAPANCT00954031
Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess
An observational study of Abscess, Peritonsillar, run by Nantes University Hospital at 15 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abscess, Peritonsillar
- How many people
- 711 participants
- Where
- 15 sitesFrance
- Study dates
- Mar 2009to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients, adult or child, including the diagnosis of APA was made, after consulting their physician
Who may be able to join
- 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
Who cannot join
- Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Angers university Hospital
Angers
Caen universty Hospital
Caen
Clermont Ferrand University Hospital
Clermont-Ferrand
Grenoble University Hospital
Grenoble
Lille University Hospital
Lille
Nantes University Hospital
Nantes, Pays de Loire, 44200
Ambroise Paré Hospital
Paris
Paris-Bichat-Hospital
Paris
Paris-Cochin Hospital
Paris
Paris-Lariboisière Hospital
Paris
Paris-Tenon-Hospital
Paris
Poitiers University Hospital
Poitiers
Rennes University hospital
Rennes
Toulouse University Hospital
Toulouse
Tours University Hosipital
Tours
About this study
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
- Conditions
- Abscess, Peritonsillar
- Medical subject headings
- Peritonsillar Abscess
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2,5 years
Secondary outcomes (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
Measured: 2,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abscess, PeritonsillarStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 711 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gilles Potel, PhD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954031
- Sponsor's protocol ID
- BRD 08/9-W
- Acronym
- APA
- Status last verified
- Jan 2013
- First submitted
- 5 Aug 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anti-inflammatory and Antibiotic Therapy on the Emergence of Peri-tonsillar Abscess
- ClinicalTrials.gov ID
- NCT00954031
- Acronym / sponsor ID
- APA / BRD 08/9-W
- Conditions
- Abscess, Peritonsillar
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 711 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients, adult or child, including the diagnosis of APA was made, after consulting their physician
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Neoplastic disease of the throat, scalable Hematologic with tonsillar localization History of tonsillectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Potel, PhD principal investigator
Nantes University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abscess, Peritonsillar, run by Nantes University Hospital at 15 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2013.