Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage (PTA)
Primary Purpose
Peritonsillar Abscess
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Clavulin
Randomization to Placebo
Clindamycin
Sponsored by
About this trial
This is an interventional treatment trial for Peritonsillar Abscess
Eligibility Criteria
Inclusion Criteria:
- Older than 18 years of age
- Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained
Exclusion Criteria:
- Pregnant
- Under the age of 18
- Bilateral peritonsillar abscesses
- Recently drained peritonsillar abscess
- Immunocomprimised
Sites / Locations
- London Health Sciences Center, St. Joseph's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antibiotic Clavulin or Clindamycin
Placebo
Arm Description
Patient's in this arm are randomized by random-number generator to receive antibiotics. This is for a 7 day course of antibiotics. Those that are allergic to penicillin will receive clindamycin. Randomization occurs after knowledge of the patient's allergy status.
Patient's randomized to this arm post-drainage will receive placebo and not receive antibiotics
Outcomes
Primary Outcome Measures
Re-accumulation of the patient's peri-tonsillar abscess
Patients will be followed up at 2 time points - 7 days and 30 days. At 7 days, the patient will be called and asked to see if they have had resolution of their symptoms. We will again call within 30 days to see if symptoms have returned within that time frame.
Secondary Outcome Measures
Full Information
NCT ID
NCT01715610
First Posted
June 15, 2012
Last Updated
November 2, 2017
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01715610
Brief Title
Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage
Acronym
PTA
Official Title
Comparing Post-drainage Treatment of Peritonsillar Abscesses With Antibiotics (Clavulin or Clindamycin) to Treating With Placebo - a Double-blinded Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Withdrawn
Why Stopped
unsuccessful recruitment
Study Start Date
May 24, 2012 (Actual)
Primary Completion Date
November 30, 2015 (Actual)
Study Completion Date
December 2, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study aims to look at the necessity for prescribing antibiotics post-drainage of peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with two arms - patients receiving placebo versus those receiving a seven day course of oral Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be phoned after 7 days to assess if their symptoms have resolved via an over the phone questionnaire. Anaerobic and aerobic cultures will be obtained.
Detailed Description
This will be a single-blinded randomized-control trial enrolling all patients presenting to otolaryngology in London, ON with a PTA. Patients will be managed in a consistent protocol amongst team members. Diagnosis of a PTA will be made by the attending physician and/or ENT team. Patients presenting symptomatology will be recorded (e.g. trismus, dysarthria, dysphagia, documented fever, etc). Previous use of antibiotics prior to presentation will also be documented, as well as use of IV antibiotics at the time of initial assessment by the ER team. After the patient has been diagnosed, the patient will be given the option to enrol in the study. If the patient agrees to enrol in the study, the following will occur. Each patient will be randomized into one of two arms - those that will receive post-drainage antibiotics versus those that will receive placebo. If randomized to the antibiotic treatment arm, then each patient will be given Amoxicillin-clavulanic acid as the antibiotic treatment of choice for 7 days unless the patient has a pencillin-allergy. If so, they will be given clindamycin. All patients will be counselled to return to hospital if their symptoms persist. In addition, each patient will be contacted after 7 days to assess if their symptoms have resolved.
The patient's abscess aspirate will be sent for culture and sensitivity. The patient's identification number will be emailed to the study administrator via confidential hospital email and the patient will be given a unique study identification code. Pertinent epidemiological data will be collected from the emergency room consultation note dictated by the treating physician and stored in a separate database.
In the microbiology laboratory, the fluid aspirate will undergo aerobic culture. Anaerobic culture will be completed on each patient's sample that arrives, providing funding for each test has been obtained. The aerobic culture of the fluid aspirate will undergo gram stain with reporting of the specific types of bacteria seen and the bacteria will then be plated, cultured and tested for sensitivities. All patients will be contacted one week after treatment to ensure clinical resolution of disease. This will be defined as resolution of symptoms, specifically trismus, odynophagia, referred otalgia, absence of dysarthria, and overall physical improvement. If persistent symptoms of recurrent abscesses are noted, appropriate follow-up will be arranged for the patient with an otolaryngologist. No confidential identifying information will be recorded in the study database. Any complications suffered by the patient will be recorded in the database.
The study will be carried out for a total of two years. Once the study is complete, all identifying data on the SIN sheet will be confidentially destroyed. No access to the study database will be available once the study is complete.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonsillar Abscess
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antibiotic Clavulin or Clindamycin
Arm Type
Active Comparator
Arm Description
Patient's in this arm are randomized by random-number generator to receive antibiotics. This is for a 7 day course of antibiotics. Those that are allergic to penicillin will receive clindamycin. Randomization occurs after knowledge of the patient's allergy status.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patient's randomized to this arm post-drainage will receive placebo and not receive antibiotics
Intervention Type
Drug
Intervention Name(s)
Clavulin
Intervention Description
Patients will be randomized to the antibiotic or placebo arm via a random number generator.
Intervention Type
Drug
Intervention Name(s)
Randomization to Placebo
Intervention Description
Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
Patients will be randomized to the antibiotic or placebo arm via a random number generator
Primary Outcome Measure Information:
Title
Re-accumulation of the patient's peri-tonsillar abscess
Description
Patients will be followed up at 2 time points - 7 days and 30 days. At 7 days, the patient will be called and asked to see if they have had resolution of their symptoms. We will again call within 30 days to see if symptoms have returned within that time frame.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Older than 18 years of age
Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained
Exclusion Criteria:
Pregnant
Under the age of 18
Bilateral peritonsillar abscesses
Recently drained peritonsillar abscess
Immunocomprimised
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Husein, MD. FRCSC
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
London Health Sciences Center, St. Joseph's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
n5x4s1
Country
Canada
12. IPD Sharing Statement
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Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage
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