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Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage (PTA)

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: NCT01715610
Recruitment Status : Withdrawn (unsuccessful recruitment)
First Posted : October 29, 2012
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Lawson Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Peritonsillar Abscess Drug: Clavulin Drug: Randomization to Placebo Drug: Clindamycin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparing Post-drainage Treatment of Peritonsillar Abscesses With Antibiotics (Clavulin or Clindamycin) to Treating With Placebo - a Double-blinded Randomized Control Trial
Actual Study Start Date : May 24, 2012
Actual Primary Completion Date : November 30, 2015
Actual Study Completion Date : December 2, 2015

Arm Intervention/treatment
Active Comparator: Antibiotic Clavulin or Clindamycin
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.
Drug: Clavulin
Patients will be randomized to the antibiotic or placebo arm via a random number generator.

Drug: Clindamycin
Patients will be randomized to the antibiotic or placebo arm via a random number generator

Placebo Comparator: Placebo
Patient's randomized to this arm post-drainage will receive placebo and not receive antibiotics
Drug: Randomization to Placebo
Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics

Primary Outcome Measures :
  1. Re-accumulation of the patient's peri-tonsillar abscess [ Time Frame: 30 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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): NCT01715610

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Canada, Ontario
London Health Sciences Center, St. Joseph's Hospital
London, Ontario, Canada, n5x4s1
Sponsors and Collaborators
Lawson Health Research Institute
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Principal Investigator: Murad Husein, MD. FRCSC Lawson Health Research Institute
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Responsible Party: Lawson Health Research Institute Identifier: NCT01715610    
Other Study ID Numbers: Lawson -REB- 101813
REB - 101813 ( Other Identifier: University of Western Ontario Research and Ethics Board )
First Posted: October 29, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Peritonsillar Abscess
Pathologic Processes
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Clindamycin palmitate
Clindamycin phosphate
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors