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

NCT01715610 | Withdrawn

• 2 other identifiers: Lawson -REB- 101813REB - 101813
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritonsillar Abscess

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days

Study Arms (2)

Antibiotic Clavulin or Clindamycin

ACTIVE COMPARATOR

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; Drug: Clindamycin

Placebo

PLACEBO COMPARATOR

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

Drug: Randomization to Placebo

Interventions

Clavulin DRUG

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

Antibiotic Clavulin or Clindamycin

Randomization to Placebo DRUG

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

Placebo

Clindamycin DRUG

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

Antibiotic Clavulin or Clindamycin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older than 18 years of age
• Diagnosed with a peritonsillar abscess that has been drained and purulence has been obtained

You may not qualify if:

• Pregnant
• Under the age of 18
• Bilateral peritonsillar abscesses
• Recently drained peritonsillar abscess
• Immunocomprimised

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Center, St. Joseph's Hospital

London, Ontario, n5x4s1, Canada

Location

MeSH Terms

Conditions

Peritonsillar Abscess

Interventions

Amoxicillin-Potassium Clavulanate Combination; Clindamycin

Condition Hierarchy (Ancestors)

Tonsillitis; Pharyngitis; Respiratory Tract Infections; Infections; Abscess; Suppuration; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides; Carbohydrates

Study Officials

• Murad Husein, MD. FRCSC

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2012
• First Posted: October 29, 2012
• Study Start: May 24, 2012
• Primary Completion: November 30, 2015
• Study Completion: December 2, 2015
• Last Updated: November 6, 2017

Record last verified: 2017-11

Locations

CA (1)