<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/NCT03809312</url>
  </required_header>
  <id_info>
    <org_study_id>ATBprophylacticCES</org_study_id>
    <nct_id>NCT03809312</nct_id>
  </id_info>
  <brief_title>The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp</brief_title>
  <official_title>The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CHU de Quebec-Universite Laval</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CHU de Quebec-Universite Laval</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blind clinical trial on the prophylactic use of antibiotics in&#xD;
      postoperative endoscopic sinus vs placebo surgery. Patients with chronic rhinosinusitis with&#xD;
      or without polyps who have consented to endoscopic sinus surgery according to Canadian&#xD;
      practice guidelines may be included in the study after approval by the Research Ethics Board&#xD;
      of the University Hospital Center. Quebec and signature of consent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The severity of the disease will be evaluated preoperatively according to the SNOT-22 score,&#xD;
      the visual analogue scale of nasal symptoms, the Lund-Mackay score on the CT-scan and the&#xD;
      Modified Lund-Kennedy endoscopic score (sinusoscopy will be recorded). Relevant demographics&#xD;
      and medical history of participants will also be collected preoperatively.&#xD;
&#xD;
      The extension of the CES and intraoperative findings will be noted. Patients who have an&#xD;
      infection during the procedure (pus with positive culture) will be excluded from the study.&#xD;
      During the surgery, 4 groups will be formed as described in the figure below. Patients will&#xD;
      be divided according to the presence or absence of polyps at the endoscopy and randomized in&#xD;
      one of the 2 groups by the pharmacy of the CHU of Quebec. This will provide either a&#xD;
      prescription of Clavulin 875 mg per os twice daily for 10 days, or a placebo of similar&#xD;
      visual appearance in the same dosage. A bioabsorbable dressing (NasoPore, Stryker) will be&#xD;
      positioned at the mid-meatus level at the end of the procedure. Nasal irrigations of saline&#xD;
      solution will be prescribed post-operatively (qid for 1 month) as well as intra-nasal&#xD;
      corticosteroids bid after 1 week (usual treatment). The addition of systemic corticosteroids&#xD;
      will be left to the judgment of the surgeon, noted and analyzed as a confounding factor.&#xD;
&#xD;
      Follow-up will be done at 2 weeks, 1 month, 3 months and 6 months post-surgery. Patients will&#xD;
      have to complete the SNOT-22 quality of life score and the visual similar scale of nasal&#xD;
      symptoms at each visit. Sinusoscopy will be recorded at scheduled visits postoperatively. A&#xD;
      single blind evaluator (to limit inter-rater differences) will analyze the video recordings&#xD;
      to establish the modified Lund-Kennedy endoscopic score for each patient. Middle-meat&#xD;
      secretion culture will be performed if pus is present during sinusoscopy and an antibiotic&#xD;
      prescribed if needed. The patient will have to fill in a diary of other medications&#xD;
      (analgesics, narcotics, anti-inflammatories) as well as a diary of side effects that will be&#xD;
      collected at the visit of a post-operative month.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 14, 2019</start_date>
  <completion_date type="Anticipated">February 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</primary_completion_date>
  <phase>Phase 4</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>
    <intervention_model_description>During the surgery, 4 groups will be formed as described in the figure below. Patients will be divided according to the presence or absence of polyps at the endoscopy and randomized in one of the 2 groups by the pharmacy of the CHU of Quebec. This will give either a prescription of Clavulin 875 mg per os to be taken twice a day for 10 days, or a placebo of similar visual appearance according to the same dosage</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Randomisation by the pharmacy, no one in the investigator and the participant will know the intervention</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Modified Lund-Kennedy endoscopic score</measure>
    <time_frame>3 months</time_frame>
    <description>The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life of patients SNOT-22</measure>
    <time_frame>3 months</time_frame>
    <description>The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Lund-Kennedy endoscopic score</measure>
    <time_frame>1 months</time_frame>
    <description>The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of infection</measure>
    <time_frame>3 months</time_frame>
    <description>Evaluate the rate of infection after endoscopic sinus surgery with or without prophylactic antibiotics, defined according to the criteria of acute bacterial rhinosinusitis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS symptoms</measure>
    <time_frame>3 months</time_frame>
    <description>The visual analogue scale is a scale containing 6 rhinological symptoms. On a 10 centimeter scale, the patient will write the important of his symptoms, 10 being the maximum and 0 the minimum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects</measure>
    <time_frame>3 months</time_frame>
    <description>Compare side effects when using prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis versus placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Lund-Kennedy endoscopic score</measure>
    <time_frame>6 months</time_frame>
    <description>The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients SNOT-22</measure>
    <time_frame>1 months</time_frame>
    <description>The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life of patients SNOT-22</measure>
    <time_frame>6 months</time_frame>
    <description>The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Chronic Sinus Infection</condition>
  <arm_group>
    <arm_group_label>Clavulin group with polyps</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group with polyps</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group who will receive placebo after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clavulin group without polyps</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group without polyps</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Amoxicillin / Clavulanic acid 875mg / 125mg</intervention_name>
    <description>Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days</description>
    <arm_group_label>Clavulin group with polyps</arm_group_label>
    <arm_group_label>Clavulin group without polyps</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>Placebos BID x 10 days</description>
    <arm_group_label>Placebo group with polyps</arm_group_label>
    <arm_group_label>Placebo group without polyps</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years old and over able to consent&#xD;
&#xD;
          -  Patients with chronic rhinosinusitis and failure to maximal medical treatment&#xD;
&#xD;
          -  Endoscopic sinus surgery with at least one of the following: maxillary antrostomy,&#xD;
             ethmoidectomy, sphenoidotomy and / or frontal sinusotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Antibiotherapy less than 2 weeks before the intervention&#xD;
&#xD;
          -  Penicillin allergy&#xD;
&#xD;
          -  Inability to establish follow-up&#xD;
&#xD;
          -  Open sinus surgery or associated septorhinoplasty (simple septoplasty is not&#xD;
             considered an exclusion criterion)&#xD;
&#xD;
          -  Immunodeficiency&#xD;
&#xD;
          -  Cystic fibrosis of the pancreas&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  odontogenic sinusitis&#xD;
&#xD;
          -  Fungal sinusitis&#xD;
&#xD;
          -  Diabetic&#xD;
&#xD;
          -  Ciliary dyskinesia&#xD;
&#xD;
          -  Sinus neoplasia&#xD;
&#xD;
          -  Patient requiring antibiotic prophylaxis for endocarditis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Simon-Pierre Harvey-Bolduc, DR</last_name>
    <phone>418-455-6167</phone>
    <email>simon-pierre.harvey-bolduc.1@ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marie-Noëlle Corriveau</last_name>
    <email>marie-noelle.corriveau@fmed.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Simon-Pierre Harvey-Bolduc</name>
      <address>
        <city>Québec</city>
        <zip>G1H0C2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Simon-Pierre Harvey-Bolduc, DR</last_name>
      <phone>418-455-6167</phone>
      <email>simon-pierre.harvey-bolduc.1@ulaval.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CHU de Quebec-Universite Laval</investigator_affiliation>
    <investigator_full_name>Simon-Pierre Harvey-Bolduc</investigator_full_name>
    <investigator_title>ENT resident</investigator_title>
  </responsible_party>
  <keyword>ESS</keyword>
  <keyword>Prophylactic antibiotics</keyword>
  <keyword>Chronic sinus infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sinusitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Amoxicillin</mesh_term>
    <mesh_term>Clavulanic Acids</mesh_term>
    <mesh_term>Clavulanic Acid</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03809312
org study id: ATBprophylacticCES
nct id: NCT03809312
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
This is a randomized, double-blind clinical trial on the prophylactic use of antibiotics in
      postoperative endoscopic sinus vs placebo surgery. Patients with chronic rhinosinusitis with
      or without polyps who have consented to endoscopic sinus surgery according to Canadian
      practice guidelines may be included in the study after approval by the Research Ethics Board
      of the University Hospital Center. Quebec and signature of consent.
The severity of the disease will be evaluated preoperatively according to the SNOT-22 score,
      the visual analogue scale of nasal symptoms, the Lund-Mackay score on the CT-scan and the
      Modified Lund-Kennedy endoscopic score (sinusoscopy will be recorded). Relevant demographics
      and medical history of participants will also be collected preoperatively.

      The extension of the CES and intraoperative findings will be noted. Patients who have an
      infection during the procedure (pus with positive culture) will be excluded from the study.
      During the surgery, 4 groups will be formed as described in the figure below. Patients will
      be divided according to the presence or absence of polyps at the endoscopy and randomized in
      one of the 2 groups by the pharmacy of the CHU of Quebec. This will provide either a
      prescription of Clavulin 875 mg per os twice daily for 10 days, or a placebo of similar
      visual appearance in the same dosage. A bioabsorbable dressing (NasoPore, Stryker) will be
      positioned at the mid-meatus level at the end of the procedure. Nasal irrigations of saline
      solution will be prescribed post-operatively (qid for 1 month) as well as intra-nasal
      corticosteroids bid after 1 week (usual treatment). The addition of systemic corticosteroids
      will be left to the judgment of the surgeon, noted and analyzed as a confounding factor.

      Follow-up will be done at 2 weeks, 1 month, 3 months and 6 months post-surgery. Patients will
      have to complete the SNOT-22 quality of life score and the visual similar scale of nasal
      symptoms at each visit. Sinusoscopy will be recorded at scheduled visits postoperatively. A
      single blind evaluator (to limit inter-rater differences) will analyze the video recordings
      to establish the modified Lund-Kennedy endoscopic score for each patient. Middle-meat
      secretion culture will be performed if pus is present during sinusoscopy and an antibiotic
      prescribed if needed. The patient will have to fill in a diary of other medications
      (analgesics, narcotics, anti-inflammatories) as well as a diary of side effects that will be
      collected at the visit of a post-operative month.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: During the surgery, 4 groups will be formed as described in the figure below. Patients will be divided according to the presence or absence of polyps at the endoscopy and randomized in one of the 2 groups by the pharmacy of the CHU of Quebec. This will give either a prescription of Clavulin 875 mg per os to be taken twice a day for 10 days, or a placebo of similar visual appearance according to the same dosage
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Randomisation by the pharmacy, no one in the investigator and the participant will know the intervention
measure: Modified Lund-Kennedy endoscopic score
time frame: 3 months
description: The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition
measure: Quality of life of patients SNOT-22
time frame: 3 months
description: The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.
measure: Modified Lund-Kennedy endoscopic score
time frame: 1 months
description: The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition
measure: Rate of infection
time frame: 3 months
description: Evaluate the rate of infection after endoscopic sinus surgery with or without prophylactic antibiotics, defined according to the criteria of acute bacterial rhinosinusitis.
measure: VAS symptoms
time frame: 3 months
description: The visual analogue scale is a scale containing 6 rhinological symptoms. On a 10 centimeter scale, the patient will write the important of his symptoms, 10 being the maximum and 0 the minimum.
measure: Side effects
time frame: 3 months
description: Compare side effects when using prophylactic antibiotics after endoscopic sinus surgery for chronic rhinosinusitis versus placebo.
measure: Modified Lund-Kennedy endoscopic score
time frame: 6 months
description: The modified Lund-Kennedy score is an endoscopic score that measures sinus involvement during endoscopy. It is divided into 2 nostrils. For each nostril, it has a score of 0 to 2 for the presence of polyp, edema and flow. The score is therefore 0 to 6 for each nostril for a maximum of 12. The higher the score, the more severe is the condition
measure: Quality of life of patients SNOT-22
time frame: 1 months
description: The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.
measure: Quality of life of patients SNOT-22
time frame: 6 months
description: The SNOT-22 score is a quality of life score. It contains 22 sinus symptoms. Each of the symptoms is scored from 0 to 5, with 0 being no problem and 5 being a severe problem. The SNOT-22 is a score of 0 to 110, the higher the score, the more severe the disease.
arm group label: Clavulin group with polyps
arm group type: Active Comparator
description: Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery
arm group label: Placebo group with polyps
arm group type: Placebo Comparator
description: Group who will receive placebo after the endoscopic sinus surgery in prophylactic and who have polyps in the surgery
arm group label: Clavulin group without polyps
arm group type: Active Comparator
description: Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery
arm group label: Placebo group without polyps
arm group type: Placebo Comparator
description: Group who will receive clavulin after the endoscopic sinus surgery in prophylactic and who haven't polyps in the surgery
intervention type: Drug
intervention name: Amoxicillin / Clavulanic acid 875mg / 125mg
description: Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
arm group label: Clavulin group with polyps
arm group label: Clavulin group without polyps
intervention type: Drug
intervention name: Placebos
description: Placebos BID x 10 days
arm group label: Placebo group with polyps
arm group label: Placebo group without polyps
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Simon-Pierre Harvey-Bolduc, DR
phone: 418-455-6167
email: simon-pierre.harvey-bolduc.1@ulaval.ca
last name: Marie-Noëlle Corriveau
email: marie-noelle.corriveau@fmed.ulaval.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: CHU de Quebec-Universite Laval
investigator full name: Simon-Pierre Harvey-Bolduc
investigator title: ENT resident
mesh term: Sinusitis
mesh term: Amoxicillin
mesh term: Clavulanic Acids
mesh term: Clavulanic Acid
sharing ipd: No