<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01715610</url>
  </required_header>
  <id_info>
    <org_study_id>Lawson -REB- 101813</org_study_id>
    <secondary_id>REB - 101813</secondary_id>
    <nct_id>NCT01715610</nct_id>
  </id_info>
  <brief_title>Assessing the Necessity of Prescribing Antibiotics (Clavulin or Clindamycin Versus Placebo) Post-peritonsillar Abscess Drainage</brief_title>
  <acronym>PTA</acronym>
  <official_title>Comparing Post-drainage Treatment of Peritonsillar Abscesses With Antibiotics (Clavulin or Clindamycin) to Treating With Placebo - a Double-blinded Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lawson Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lawson Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to look at the necessity for prescribing antibiotics post-drainage of&#xD;
      peritonsillar abscesses (PTA). This will be a single-blinded randomized-control trial with&#xD;
      two arms - patients receiving placebo versus those receiving a seven day course of oral&#xD;
      Amoxicillin-Clavulanic acid. The main objective measure will be to assess if there is&#xD;
      resolution of the peri-tonsillar abscess and there has been no reaccumulation. Patients will&#xD;
      be blinded to whether they receive placebo or amoxicillin-clavulanic acid. Patients will be&#xD;
      phoned after 7 days to assess if their symptoms have resolved via an over the phone&#xD;
      questionnaire. Anaerobic and aerobic cultures will be obtained.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a single-blinded randomized-control trial enrolling all patients presenting to&#xD;
      otolaryngology in London, ON with a PTA. Patients will be managed in a consistent protocol&#xD;
      amongst team members. Diagnosis of a PTA will be made by the attending physician and/or ENT&#xD;
      team. Patients presenting symptomatology will be recorded (e.g. trismus, dysarthria,&#xD;
      dysphagia, documented fever, etc). Previous use of antibiotics prior to presentation will&#xD;
      also be documented, as well as use of IV antibiotics at the time of initial assessment by the&#xD;
      ER team. After the patient has been diagnosed, the patient will be given the option to enrol&#xD;
      in the study. If the patient agrees to enrol in the study, the following will occur. Each&#xD;
      patient will be randomized into one of two arms - those that will receive post-drainage&#xD;
      antibiotics versus those that will receive placebo. If randomized to the antibiotic treatment&#xD;
      arm, then each patient will be given Amoxicillin-clavulanic acid as the antibiotic treatment&#xD;
      of choice for 7 days unless the patient has a pencillin-allergy. If so, they will be given&#xD;
      clindamycin. All patients will be counselled to return to hospital if their symptoms persist.&#xD;
      In addition, each patient will be contacted after 7 days to assess if their symptoms have&#xD;
      resolved.&#xD;
&#xD;
      The patient's abscess aspirate will be sent for culture and sensitivity. The patient's&#xD;
      identification number will be emailed to the study administrator via confidential hospital&#xD;
      email and the patient will be given a unique study identification code. Pertinent&#xD;
      epidemiological data will be collected from the emergency room consultation note dictated by&#xD;
      the treating physician and stored in a separate database.&#xD;
&#xD;
      In the microbiology laboratory, the fluid aspirate will undergo aerobic culture. Anaerobic&#xD;
      culture will be completed on each patient's sample that arrives, providing funding for each&#xD;
      test has been obtained. The aerobic culture of the fluid aspirate will undergo gram stain&#xD;
      with reporting of the specific types of bacteria seen and the bacteria will then be plated,&#xD;
      cultured and tested for sensitivities. All patients will be contacted one week after&#xD;
      treatment to ensure clinical resolution of disease. This will be defined as resolution of&#xD;
      symptoms, specifically trismus, odynophagia, referred otalgia, absence of dysarthria, and&#xD;
      overall physical improvement. If persistent symptoms of recurrent abscesses are noted,&#xD;
      appropriate follow-up will be arranged for the patient with an otolaryngologist. No&#xD;
      confidential identifying information will be recorded in the study database. Any&#xD;
      complications suffered by the patient will be recorded in the database.&#xD;
&#xD;
      The study will be carried out for a total of two years. Once the study is complete, all&#xD;
      identifying data on the SIN sheet will be confidentially destroyed. No access to the study&#xD;
      database will be available once the study is complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    unsuccessful recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">May 24, 2012</start_date>
  <completion_date type="Actual">December 2, 2015</completion_date>
  <primary_completion_date type="Actual">November 30, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Re-accumulation of the patient's peri-tonsillar abscess</measure>
    <time_frame>30 days</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Peritonsillar Abscess</condition>
  <arm_group>
    <arm_group_label>Antibiotic Clavulin or Clindamycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patient's randomized to this arm post-drainage will receive placebo and not receive antibiotics</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clavulin</intervention_name>
    <description>Patients will be randomized to the antibiotic or placebo arm via a random number generator.</description>
    <arm_group_label>Antibiotic Clavulin or Clindamycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Randomization to Placebo</intervention_name>
    <description>Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clindamycin</intervention_name>
    <description>Patients will be randomized to the antibiotic or placebo arm via a random number generator</description>
    <arm_group_label>Antibiotic Clavulin or Clindamycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 18 years of age&#xD;
&#xD;
          -  Diagnosed with a peritonsillar abscess that has been drained and purulence has been&#xD;
             obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Bilateral peritonsillar abscesses&#xD;
&#xD;
          -  Recently drained peritonsillar abscess&#xD;
&#xD;
          -  Immunocomprimised&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Murad Husein, MD. FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lawson Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>London Health Sciences Center, St. Joseph's Hospital</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>n5x4s1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>June 15, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>November 2, 2017</last_update_submitted>
  <last_update_submitted_qc>November 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abscess</mesh_term>
    <mesh_term>Peritonsillar Abscess</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Clindamycin</mesh_term>
    <mesh_term>Clindamycin palmitate</mesh_term>
    <mesh_term>Clindamycin phosphate</mesh_term>
    <mesh_term>Amoxicillin-Potassium Clavulanate Combination</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01715610
org study id: Lawson -REB- 101813
secondary id: REB - 101813
nct id: NCT01715610
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Re-accumulation of the patient's peri-tonsillar abscess
time frame: 30 days
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.
arm group label: Antibiotic Clavulin or Clindamycin
arm group type: Active Comparator
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 group label: Placebo
arm group type: Placebo Comparator
description: Patient's randomized to this arm post-drainage will receive placebo and not receive antibiotics
intervention type: Drug
intervention name: Clavulin
description: Patients will be randomized to the antibiotic or placebo arm via a random number generator.
arm group label: Antibiotic Clavulin or Clindamycin
intervention type: Drug
intervention name: Randomization to Placebo
description: Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics
arm group label: Placebo
intervention type: Drug
intervention name: Clindamycin
description: Patients will be randomized to the antibiotic or placebo arm via a random number generator
arm group label: Antibiotic Clavulin or Clindamycin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Murad Husein, MD. FRCSC
role: Principal Investigator
affiliation: Lawson Health Research Institute
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Abscess
mesh term: Peritonsillar Abscess
mesh term: Clindamycin
mesh term: Clindamycin palmitate
mesh term: Clindamycin phosphate
mesh term: Amoxicillin-Potassium Clavulanate Combination