<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/NCT04471246</url>
  </required_header>
  <id_info>
    <org_study_id>20200175</org_study_id>
    <nct_id>NCT04471246</nct_id>
  </id_info>
  <brief_title>High-dose vs. Standard-dose Cephalexin for Cellulitis</brief_title>
  <official_title>High-dose Cephalexin for Cellulitis: A Pilot Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Hospital Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Ottawa Hospital Academic Medical Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Canadian Association of Emergency Physicians</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Ottawa Hospital Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cellulitis is a painful bacterial infection of the skin and underlying tissue that needs&#xD;
      antibiotic treatment. There are approximately 193,000 visits to Canadian emergency&#xD;
      departments (EDs) each year for cellulitis. Emergency doctors who treat patients with&#xD;
      cellulitis must decide on the correct antibiotic agent, dose, duration and frequency.&#xD;
      Cellulitis is most commonly treated with the oral antibiotic cephalexin. However, there has&#xD;
      been little research to guide doctors with respect to cellulitis treatment, which has led to&#xD;
      an overuse of intravenous antibiotics. In addition, the current treatment failure rate of 20%&#xD;
      is unacceptably high. When compared to standard-dose oral cephalexin, high-dose oral&#xD;
      cephalexin may reduce treatment failure, which would help decrease the need for intravenous&#xD;
      antibiotics and subsequent hospitalization. A well-designed clinical trial is necessary to&#xD;
      determine if high-dose oral cephalexin reduces treatment failure for cellulitis patients.&#xD;
      This pilot trial will determine the feasibility and design of such a clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Cellulitis is a common clinical condition that represents up to 3% of all&#xD;
      emergency department (ED) visits. The current treatment failure rate is approximately 20%.&#xD;
      This high treatment failure rate may be due to suboptimal dosing of cephalexin. The&#xD;
      Investigators hypothesize that high-dose cephalexin may lead to lower rates of treatment&#xD;
      failure and subsequently improved patient outcomes (less hospitalizations and avoidance of&#xD;
      intravenous antibiotics)&#xD;
&#xD;
      Rationale: Before embarking on a large, multicenter trial, it is essential to conduct a&#xD;
      smaller pilot to test and refine study procedures and to demonstrate feasibility.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Design: The investigators will conduct a parallel arm double-blind randomized controlled&#xD;
      pilot trial at the Civic and General campus ED of The Ottawa Hospital (TOH). The study will&#xD;
      operate seven days a week from 0800 to 2000 over a 6-month timeframe. TOH Pharmacy will&#xD;
      follow a randomization sequence and prepare study medication packages. Study medication&#xD;
      packages will be dispensed to the patient by a registered nurse (RN).&#xD;
&#xD;
      Patients: Adult (age &gt;=18 years) ED patient with non-purulent cellulitis determined by the&#xD;
      treating emergency physician to be eligible for outpatient care with oral antibiotics.&#xD;
&#xD;
      Intervention: High-dose cephalexin (1000 mg PO QID) for seven days.&#xD;
&#xD;
      Comparator: Standard-dose cephalexin (500 mg PO QID) plus placebo for seven days.&#xD;
&#xD;
      Primary Feasibility Outcome: Patient recruitment rate (percentage of approached eligible&#xD;
      patients who are successfully recruited). The goal is to recruit at least 29% of eligible&#xD;
      patients.&#xD;
&#xD;
      Primary Effectiveness Outcome: 1. Oral antibiotic treatment failure, defined as a change in&#xD;
      antibiotic (change in class of oral antibiotic or step up to intravenous therapy) within 7&#xD;
      days due to worsening infection, which is defined as:&#xD;
&#xD;
        1. New fever (temperature ≥ 38.0C) or persistent fever at Day 3 follow up; or&#xD;
&#xD;
        2. Increasing area of erythema ≥20% from baseline; or&#xD;
&#xD;
        3. Increasing pain ≥2 points from baseline (numeric rating scale)&#xD;
&#xD;
      The secondary effectiveness outcomes are:&#xD;
&#xD;
        1. Clinical cure (no erythema, pain and fever) at day 7&#xD;
&#xD;
        2. Clinical response (≥20% reduction in area of erythema compared to baseline) at day 3&#xD;
&#xD;
        3. Adverse events (e.g. vomiting, diarrhea, rash) at 14-day telephone follow-up&#xD;
&#xD;
        4. Unplanned i) return ED visits; and ii) hospitalization at 14-day telephone follow-up&#xD;
&#xD;
      Importance: This pilot trial will be the first to compare high-dose cephalexin to&#xD;
      standard-dose cephalexin for ED patients with cellulitis. The results of this pilot&#xD;
      randomized trial will help inform the design and implementation of a larger, multicenter&#xD;
      randomized controlled trial to answer this important clinical question.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2021</start_date>
  <completion_date type="Actual">February 23, 2022</completion_date>
  <primary_completion_date type="Actual">February 23, 2022</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>The Investigators will conduct a parallel arm double-blind randomized controlled pilot trial.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Eligible patients will be randomized (1:1) to high-dose versus standard-dose arms. The randomization sequence will be computer-generated by a statistician</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient recruitment rate</measure>
    <time_frame>6 months</time_frame>
    <description>% of patients recruited into the trial</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral antibiotic treatment failure</measure>
    <time_frame>6 months</time_frame>
    <description>% of patients with oral antibiotic treatment failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ability to approach eligible patients</measure>
    <time_frame>6 months</time_frame>
    <description>% of eligible patients that are approached for consent to enter into the trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of blinding</measure>
    <time_frame>7 days</time_frame>
    <description>Assessment of blinding via a patient questionnaire (participant will be asked to indicate which treatment they believe they received) at end of therapy (7 days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protocol adherence</measure>
    <time_frame>7 days</time_frame>
    <description>% of patients that are adherent to allocated treatment for 7 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss to follow up</measure>
    <time_frame>14 days</time_frame>
    <description>% of patients lost to follow up at 14 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical cure</measure>
    <time_frame>7 days</time_frame>
    <description>% of patients with clinical cure (no erythema, pain and fever) at days 3 and 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>14 days</time_frame>
    <description>% of patients with adverse events (e.g. vomiting, diarrhea, rash) at 14-days measured via telephone follow-up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unplanned ED Visits or Hospitalization</measure>
    <time_frame>14 days</time_frame>
    <description>% of patients with unplanned i) return ED visits; and ii) hospitalization, measured via 14-day telephone follow-up</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Cellulitis</condition>
  <arm_group>
    <arm_group_label>High Dose Cephalexin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention is high-dose cephalexin (1000mg PO QID) for seven days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Dose Cephalexin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The comparator is standard-dose cephalexin (500mg PO QID) plus oral placebo for seven days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cephalexin</intervention_name>
    <description>1000 mg PO QID for 7 days</description>
    <arm_group_label>High Dose Cephalexin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cephalexin</intervention_name>
    <description>500 mg PO QID plus oral placebo for 7 days</description>
    <arm_group_label>Standard Dose Cephalexin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults (age &gt;=18 years) with non-purulent cellulitis determined by the treating emergency&#xD;
        physician to be eligible for outpatient care with oral antibiotics.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt;18 years&#xD;
&#xD;
          2. Patient already taking oral antibiotics&#xD;
&#xD;
          3. Treating physician decides that intravenous therapy is required&#xD;
&#xD;
          4. Abscess requiring an incision and drainage or needle aspiration procedure&#xD;
&#xD;
          5. Known prior cellulitis secondary to methicillin-resistant Staphylococcus aureus&#xD;
&#xD;
          6. Cellulitis secondary to a human or animal bite wound&#xD;
&#xD;
          7. Surgical site infection&#xD;
&#xD;
          8. Malignancy and currently being treated with chemotherapy&#xD;
&#xD;
          9. Febrile neutropenia (temperature &gt;=38C plus absolute neutrophil count &lt;500 cells/uL)&#xD;
&#xD;
         10. Solid organ or bone marrow transplant recipient&#xD;
&#xD;
         11. Renal impairment with creatinine clearance &lt;30 mL/min&#xD;
&#xD;
         12. Pregnant or breastfeeding&#xD;
&#xD;
         13. Allergy to cephalosporins or history of anaphylaxis to penicillin&#xD;
&#xD;
         14. Inability to provide consent&#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>Krishan Yadav, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Hospital Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Ottawa Hospital</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1y 4E9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>Stevens DL, Eron LL. In the clinic. Cellulitis and soft-tissue infections. Ann Intern Med. 2009 Jan 6;150(1):ITC11. doi: 10.7326/0003-4819-150-1-200901060-01001.</citation>
    <PMID>19124814</PMID>
  </results_reference>
  <results_reference>
    <citation>Stenstrom R, Grafstein E, Romney M, Fahimi J, Harris D, Hunte G, Innes G, Christenson J. Prevalence of and risk factors for methicillin-resistant Staphylococcus aureus skin and soft tissue infection in a Canadian emergency department. CJEM. 2009 Sep;11(5):430-8. doi: 10.1017/s1481803500011623. Erratum In: CJEM. 2009 Nov;11(6):570.</citation>
    <PMID>19788787</PMID>
  </results_reference>
  <results_reference>
    <citation>Yadav K, Suh KN, Eagles D, MacIsaac J, Ritchie D, Bernick J, Thiruganasambandamoorthy V, Wells G, Stiell IG. Predictors of Oral Antibiotic Treatment Failure for Nonpurulent Skin and Soft Tissue Infections in the Emergency Department. Acad Emerg Med. 2019 Jan;26(1):51-59. doi: 10.1111/acem.13492. Epub 2018 Jul 4.</citation>
    <PMID>29869364</PMID>
  </results_reference>
  <results_reference>
    <citation>Pollack CV Jr, Amin A, Ford WT Jr, Finley R, Kaye KS, Nguyen HH, Rybak MJ, Talan D. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. J Emerg Med. 2015 Apr;48(4):508-19. doi: 10.1016/j.jemermed.2014.12.001. Epub 2015 Jan 17.</citation>
    <PMID>25605319</PMID>
  </results_reference>
  <results_reference>
    <citation>Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jul 15;59(2):e10-52. doi: 10.1093/cid/ciu444. Erratum In: Clin Infect Dis. 2015 May 1;60(9):1448. Dosage error in article text.</citation>
    <PMID>24973422</PMID>
  </results_reference>
  <results_reference>
    <citation>Kwak YG, Choi SH, Kim T, Park SY, Seo SH, Kim MB, Choi SH. Clinical Guidelines for the Antibiotic Treatment for Community-Acquired Skin and Soft Tissue Infection. Infect Chemother. 2017 Dec;49(4):301-325. doi: 10.3947/ic.2017.49.4.301.</citation>
    <PMID>29299899</PMID>
  </results_reference>
  <results_reference>
    <citation>Li HK, Agweyu A, English M, Bejon P. An unsupported preference for intravenous antibiotics. PLoS Med. 2015 May 19;12(5):e1001825. doi: 10.1371/journal.pmed.1001825. eCollection 2015 May.</citation>
    <PMID>25992781</PMID>
  </results_reference>
  <results_reference>
    <citation>Cyriac JM, James E. Switch over from intravenous to oral therapy: A concise overview. J Pharmacol Pharmacother. 2014 Apr;5(2):83-7. doi: 10.4103/0976-500X.130042.</citation>
    <PMID>24799810</PMID>
  </results_reference>
  <results_reference>
    <citation>Yadav K, Gatien M, Corrales-Medina V, Stiell I. Antimicrobial treatment decision for non-purulent skin and soft tissue infections in the emergency department. CJEM. 2017 May;19(3):175-180. doi: 10.1017/cem.2016.347. Epub 2016 Aug 17.</citation>
    <PMID>27531595</PMID>
  </results_reference>
  <results_reference>
    <citation>Chow M, Quintiliani R, Cunha BA, Thompson M, Finkelstein E, Nightingale CH. Pharmacokinetics of high-dose oral cephalosporins. J Clin Pharmacol. 1979 Apr;19(4):185-94. doi: 10.1002/j.1552-4604.1979.tb01650.x. No abstract available.</citation>
    <PMID>438352</PMID>
  </results_reference>
  <results_reference>
    <citation>Wise R. The pharmacokinetics of the oral cephalosporins--a review. J Antimicrob Chemother. 1990 Dec;26 Suppl E:13-20. doi: 10.1093/jac/26.suppl_e.13.</citation>
    <PMID>2292525</PMID>
  </results_reference>
  <results_reference>
    <citation>Murray H, Stiell I, Wells G. Treatment failure in emergency department patients with cellulitis. CJEM. 2005 Jul;7(4):228-34. doi: 10.1017/s1481803500014342.</citation>
    <PMID>17355677</PMID>
  </results_reference>
  <results_reference>
    <citation>Peterson D, McLeod S, Woolfrey K, McRae A. Predictors of failure of empiric outpatient antibiotic therapy in emergency department patients with uncomplicated cellulitis. Acad Emerg Med. 2014 May;21(5):526-31. doi: 10.1111/acem.12371.</citation>
    <PMID>24842503</PMID>
  </results_reference>
  <results_reference>
    <citation>Yadav K, Nath A, Suh KN, Sikora L, Eagles D. Treatment failure definitions for non-purulent skin and soft tissue infections: a systematic review. Infection. 2020 Feb;48(1):75-83. doi: 10.1007/s15010-019-01347-w. Epub 2019 Aug 5.</citation>
    <PMID>31378847</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>April 26, 2022</last_update_submitted>
  <last_update_submitted_qc>April 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2022</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>Cellulitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cephalexin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 14, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04471246
org study id: 20200175
nct id: NCT04471246
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cellulitis is a painful bacterial infection of the skin and underlying tissue that needs
      antibiotic treatment. There are approximately 193,000 visits to Canadian emergency
      departments (EDs) each year for cellulitis. Emergency doctors who treat patients with
      cellulitis must decide on the correct antibiotic agent, dose, duration and frequency.
      Cellulitis is most commonly treated with the oral antibiotic cephalexin. However, there has
      been little research to guide doctors with respect to cellulitis treatment, which has led to
      an overuse of intravenous antibiotics. In addition, the current treatment failure rate of 20%
      is unacceptably high. When compared to standard-dose oral cephalexin, high-dose oral
      cephalexin may reduce treatment failure, which would help decrease the need for intravenous
      antibiotics and subsequent hospitalization. A well-designed clinical trial is necessary to
      determine if high-dose oral cephalexin reduces treatment failure for cellulitis patients.
      This pilot trial will determine the feasibility and design of such a clinical trial.
Background: Cellulitis is a common clinical condition that represents up to 3% of all
      emergency department (ED) visits. The current treatment failure rate is approximately 20%.
      This high treatment failure rate may be due to suboptimal dosing of cephalexin. The
      Investigators hypothesize that high-dose cephalexin may lead to lower rates of treatment
      failure and subsequently improved patient outcomes (less hospitalizations and avoidance of
      intravenous antibiotics)

      Rationale: Before embarking on a large, multicenter trial, it is essential to conduct a
      smaller pilot to test and refine study procedures and to demonstrate feasibility.

      Methods:

      Design: The investigators will conduct a parallel arm double-blind randomized controlled
      pilot trial at the Civic and General campus ED of The Ottawa Hospital (TOH). The study will
      operate seven days a week from 0800 to 2000 over a 6-month timeframe. TOH Pharmacy will
      follow a randomization sequence and prepare study medication packages. Study medication
      packages will be dispensed to the patient by a registered nurse (RN).

      Patients: Adult (age >=18 years) ED patient with non-purulent cellulitis determined by the
      treating emergency physician to be eligible for outpatient care with oral antibiotics.

      Intervention: High-dose cephalexin (1000 mg PO QID) for seven days.

      Comparator: Standard-dose cephalexin (500 mg PO QID) plus placebo for seven days.

      Primary Feasibility Outcome: Patient recruitment rate (percentage of approached eligible
      patients who are successfully recruited). The goal is to recruit at least 29% of eligible
      patients.

      Primary Effectiveness Outcome: 1. Oral antibiotic treatment failure, defined as a change in
      antibiotic (change in class of oral antibiotic or step up to intravenous therapy) within 7
      days due to worsening infection, which is defined as:

        1. New fever (temperature ≥ 38.0C) or persistent fever at Day 3 follow up; or

        2. Increasing area of erythema ≥20% from baseline; or

        3. Increasing pain ≥2 points from baseline (numeric rating scale)

      The secondary effectiveness outcomes are:

        1. Clinical cure (no erythema, pain and fever) at day 7

        2. Clinical response (≥20% reduction in area of erythema compared to baseline) at day 3

        3. Adverse events (e.g. vomiting, diarrhea, rash) at 14-day telephone follow-up

        4. Unplanned i) return ED visits; and ii) hospitalization at 14-day telephone follow-up

      Importance: This pilot trial will be the first to compare high-dose cephalexin to
      standard-dose cephalexin for ED patients with cellulitis. The results of this pilot
      randomized trial will help inform the design and implementation of a larger, multicenter
      randomized controlled trial to answer this important clinical question.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The Investigators will conduct a parallel arm double-blind randomized controlled pilot trial.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Eligible patients will be randomized (1:1) to high-dose versus standard-dose arms. The randomization sequence will be computer-generated by a statistician
measure: Patient recruitment rate
time frame: 6 months
description: % of patients recruited into the trial
measure: Oral antibiotic treatment failure
time frame: 6 months
description: % of patients with oral antibiotic treatment failure
measure: Ability to approach eligible patients
time frame: 6 months
description: % of eligible patients that are approached for consent to enter into the trial
measure: Assessment of blinding
time frame: 7 days
description: Assessment of blinding via a patient questionnaire (participant will be asked to indicate which treatment they believe they received) at end of therapy (7 days)
measure: Protocol adherence
time frame: 7 days
description: % of patients that are adherent to allocated treatment for 7 days
measure: Loss to follow up
time frame: 14 days
description: % of patients lost to follow up at 14 days
measure: Clinical cure
time frame: 7 days
description: % of patients with clinical cure (no erythema, pain and fever) at days 3 and 7
measure: Adverse events
time frame: 14 days
description: % of patients with adverse events (e.g. vomiting, diarrhea, rash) at 14-days measured via telephone follow-up
measure: Unplanned ED Visits or Hospitalization
time frame: 14 days
description: % of patients with unplanned i) return ED visits; and ii) hospitalization, measured via 14-day telephone follow-up
arm group label: High Dose Cephalexin
arm group type: Experimental
description: The intervention is high-dose cephalexin (1000mg PO QID) for seven days
arm group label: Standard Dose Cephalexin
arm group type: Active Comparator
description: The comparator is standard-dose cephalexin (500mg PO QID) plus oral placebo for seven days
intervention type: Drug
intervention name: Cephalexin
description: 1000 mg PO QID for 7 days
arm group label: High Dose Cephalexin
intervention type: Drug
intervention name: Cephalexin
description: 500 mg PO QID plus oral placebo for 7 days
arm group label: Standard Dose Cephalexin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Krishan Yadav, MD, MSc
role: Principal Investigator
affiliation: Ottawa Hospital Research Institute
facility: 
country: Canada
citation: Stevens DL, Eron LL. In the clinic. Cellulitis and soft-tissue infections. Ann Intern Med. 2009 Jan 6;150(1):ITC11. doi: 10.7326/0003-4819-150-1-200901060-01001.
PMID: 19124814
citation: Stenstrom R, Grafstein E, Romney M, Fahimi J, Harris D, Hunte G, Innes G, Christenson J. Prevalence of and risk factors for methicillin-resistant Staphylococcus aureus skin and soft tissue infection in a Canadian emergency department. CJEM. 2009 Sep;11(5):430-8. doi: 10.1017/s1481803500011623. Erratum In: CJEM. 2009 Nov;11(6):570.
PMID: 19788787
citation: Yadav K, Suh KN, Eagles D, MacIsaac J, Ritchie D, Bernick J, Thiruganasambandamoorthy V, Wells G, Stiell IG. Predictors of Oral Antibiotic Treatment Failure for Nonpurulent Skin and Soft Tissue Infections in the Emergency Department. Acad Emerg Med. 2019 Jan;26(1):51-59. doi: 10.1111/acem.13492. Epub 2018 Jul 4.
PMID: 29869364
citation: Pollack CV Jr, Amin A, Ford WT Jr, Finley R, Kaye KS, Nguyen HH, Rybak MJ, Talan D. Acute bacterial skin and skin structure infections (ABSSSI): practice guidelines for management and care transitions in the emergency department and hospital. J Emerg Med. 2015 Apr;48(4):508-19. doi: 10.1016/j.jemermed.2014.12.001. Epub 2015 Jan 17.
PMID: 25605319
citation: Stevens DL, Bisno AL, Chambers HF, Dellinger EP, Goldstein EJ, Gorbach SL, Hirschmann JV, Kaplan SL, Montoya JG, Wade JC; Infectious Diseases Society of America. Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the Infectious Diseases Society of America. Clin Infect Dis. 2014 Jul 15;59(2):e10-52. doi: 10.1093/cid/ciu444. Erratum In: Clin Infect Dis. 2015 May 1;60(9):1448. Dosage error in article text.
PMID: 24973422
citation: Kwak YG, Choi SH, Kim T, Park SY, Seo SH, Kim MB, Choi SH. Clinical Guidelines for the Antibiotic Treatment for Community-Acquired Skin and Soft Tissue Infection. Infect Chemother. 2017 Dec;49(4):301-325. doi: 10.3947/ic.2017.49.4.301.
PMID: 29299899
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responsible party type: Sponsor
mesh term: Cellulitis
mesh term: Cephalexin
sharing ipd: No
submitted: April 14, 2023