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

NCT ID: NCT01715610

Last Updated: 2017-11-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-24
• Study Completion Date: 2015-12-02

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.

Conditions

Peritonsillar Abscess

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Clavulin

Intervention Type: DRUG

Patients will be randomized to the antibiotic or placebo arm via a random number generator.

Clindamycin

Intervention Type: DRUG

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

Placebo

Patient's randomized to this arm post-drainage will receive placebo and not receive antibiotics

Group Type: PLACEBO_COMPARATOR

Randomization to Placebo

Intervention Type: DRUG

Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics

Interventions

Clavulin

Patients will be randomized to the antibiotic or placebo arm via a random number generator.

Intervention Type: DRUG

Randomization to Placebo

Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics

Intervention Type: DRUG

Clindamycin

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murad Husein, MD. FRCSC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Locations

London Health Sciences Center, St. Joseph's Hospital

London, Ontario, Canada

Countries

Canada

Other Identifiers

REB - 101813

Identifier Type: OTHER

Identifier Source: secondary_id

Lawson -REB- 101813

Identifier Type: -

Identifier Source: org_study_id