<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/NCT02230813</url>
  </required_header>
  <id_info>
    <org_study_id>14/53</org_study_id>
    <nct_id>NCT02230813</nct_id>
  </id_info>
  <brief_title>Predictors of Oral Antibiotic Treatment Failure in Emergency Department Patients With Cellulitis</brief_title>
  <official_title>Prevalence and Predictors of Initial Oral Antibiotic Treatment Failure in Adult Emergency Department Patients With Cellulitis: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Royal College of Surgeons, Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Royal College of Surgeons, Ireland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The term cellulitis is a medical term describing a bacterial infection of the skin and&#xD;
      tissues beneath the skin. Although it is usually easily treated with antibiotics given either&#xD;
      orally or through a vein (intravenously), knowing which route of antibiotic treatment to&#xD;
      prescribe to a person attending an Emergency Department with cellulitis is not clear.&#xD;
&#xD;
      A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research&#xD;
      as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which&#xD;
      patients require oral and which patients require intravenous antibiotics for cellulitis from&#xD;
      their first visit to an emergency department. The aim of this is to provide safer care by&#xD;
      reducing the risk of a patient returning to the hospital with a worsening infection. It will&#xD;
      also promote more cost-effective care by reducing hospital re-attendance rates and wasted&#xD;
      antibiotics.&#xD;
&#xD;
      Patients attending the department with cellulitis who are suitable for oral antibiotic&#xD;
      treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of&#xD;
      study participants in order to reduce bias. A set of physical signs and symptoms will be&#xD;
      recorded from each patient in order to determine which ones are associated with them&#xD;
      &quot;failing&quot; prescribed oral treatment. A study investigator will then phone the patient after&#xD;
      14 days to see whether they are better or whether they required intravenous antibiotics to&#xD;
      get better.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">September 27, 2016</completion_date>
  <primary_completion_date type="Actual">September 27, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment failure</measure>
    <time_frame>2 weeks post commencement of oral treatment</time_frame>
    <description>The primary outcome is the proportion of patients initially commenced on oral antibiotics who subsequently require IV antibiotics to achieve treatment response. This will be assessed by means of telephone follow-up performed at 14 days post enrolment into the study. Treatment failure is defined as attendance at a treating Emergency Department for intravenous antibiotic therapy if already commenced on oral therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment failure - change in type or dose</measure>
    <time_frame>2 weeks</time_frame>
    <description>Treatment failure measured by change in prescribed oral antibiotic to another oral antibiotic.&#xD;
Treatment failure measured by change in prescribed dose of oral antibiotic to a higher dose of the same antibiotic</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-observer reliability for candidate predictor variables</measure>
    <time_frame>At enrolment</time_frame>
    <description>Assessment of inter-observer reliability for the candidate predictor variables listed. This will be performed in at least 10% of patients enrolled into the study by a second recruiting clinician.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Loss to follow up</measure>
    <time_frame>2 weeks</time_frame>
    <description>Assessment of the loss to follow-up rate and usefulness of the data collection proforma in the pilot study will also prove valuable for planning for the live study.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">152</enrollment>
  <condition>Cellulitis</condition>
  <arm_group>
    <arm_group_label>Oral antibiotic therapy</arm_group_label>
    <description>Consecutive adult patients attending the study Emergency Departments with cellulitis will be considered eligible for recruitment to the study. Only those patients deemed suitable for oral antibiotic therapy and planned for discharge will be recruited to the study. Oral antibiotic therapy prescribed will be dependent on local institutional prescribing guidelines. For the purposes of the sites enrolling participants, the antibiotic of choice is oral flucloxacillin 500 milligrams four times daily for seven days. We will be assessing the treatment failure rate for this cohort of patients; namely, the number of patients requiring the primary outcome (change from oral to intravenous antibiotic therapy). We will also assess this group of patient for the secondary outcomes listed above.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients aged &gt;16 years attending the ED with cellulitis as the primary diagnosis&#xD;
        will be consecutively recruited. Only patients who are deemed suitable for an oral&#xD;
        antibiotic will be enrolled. Patients who require IV therapy will not be enrolled.&#xD;
        Cellulitis may arise de novo, or from a recognised cause such as a wound or ulcer. In order&#xD;
        to generate an externally valid clinical prediction rule, we will include all patients&#xD;
        attending the ED with cellulitis, including those who may have already been commenced on&#xD;
        oral antibiotics (for example, by their general practitioner).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;16 years&#xD;
&#xD;
          -  Suitable for treatment with flucloxacillin 500mg -1gram qds monotherapy or a suitable&#xD;
             alternative for penicillin allergic patients as listed in the local prescribing&#xD;
             guidelines.&#xD;
&#xD;
          -  Appearance of typical, plaque-like area of erythema over any body part excluding the&#xD;
             perineum within the preceding 5 days with any 2 of the following signs:&#xD;
&#xD;
          -  1.Increased warmth over affected area&#xD;
&#xD;
          -  2.Swelling of affected area&#xD;
&#xD;
          -  3.Pain over affected area&#xD;
&#xD;
          -  4.Regional lymphadenopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement for IV antibiotics as decided by the treating clinician.&#xD;
&#xD;
          -  Age less than 16 years.&#xD;
&#xD;
          -  No telephone or access to a telephone.&#xD;
&#xD;
          -  Abscess alone without co-existing signs of cellulitis&#xD;
&#xD;
          -  Mammalian bite wounds.&#xD;
&#xD;
          -  Infected diabetic foot ulcer&#xD;
&#xD;
          -  Necrotising soft tissue infections.&#xD;
&#xD;
          -  Perineal cellulitis.&#xD;
&#xD;
          -  Suspected septic arthritis or osteomyelitis.&#xD;
&#xD;
          -  Decubitus ulcers.&#xD;
&#xD;
          -  Bilateral cellulitis (as this entity rarely exists).&#xD;
&#xD;
          -  Acute lipodermatosclerosis.&#xD;
&#xD;
          -  Acute dermatitis.&#xD;
&#xD;
          -  Venous stasis dermatitis.&#xD;
&#xD;
          -  Deep vein thrombosis.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Cognitive impairment.&#xD;
&#xD;
          -  Any patient who through language barrier or diminished capacity is unable to&#xD;
             understand the scope of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abel Wakai, MD FRCS FCEM</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal College of Surgeons, Ireland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Connolly Hospital Banchardstown</name>
      <address>
        <city>Dublin 15</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emergency Department Beaumont Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mater Misericoridiae University Hospital</name>
      <address>
        <city>Dublin</city>
        <country>Ireland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Ireland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cohort Study,</keyword>
  <keyword>Cellulitis,</keyword>
  <keyword>Skin and Soft Tissue Infection,</keyword>
  <keyword>Emergency Department,</keyword>
  <keyword>Clinical Prediction Rule</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cellulitis</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02230813
org study id: 14/53
nct id: NCT02230813
lead sponsor: 
has dmc: No
The term cellulitis is a medical term describing a bacterial infection of the skin and
      tissues beneath the skin. Although it is usually easily treated with antibiotics given either
      orally or through a vein (intravenously), knowing which route of antibiotic treatment to
      prescribe to a person attending an Emergency Department with cellulitis is not clear.

      A Clinical Prediction rule (CPR) is a decision-making tool that comes from original research
      as opposed to the opinion of experts. We intend to create a preliminary CPR to decide which
      patients require oral and which patients require intravenous antibiotics for cellulitis from
      their first visit to an emergency department. The aim of this is to provide safer care by
      reducing the risk of a patient returning to the hospital with a worsening infection. It will
      also promote more cost-effective care by reducing hospital re-attendance rates and wasted
      antibiotics.

      Patients attending the department with cellulitis who are suitable for oral antibiotic
      treatment will be enrolled into this study. A separate doctor will re-examine at least 10% of
      study participants in order to reduce bias. A set of physical signs and symptoms will be
      recorded from each patient in order to determine which ones are associated with them
      "failing" prescribed oral treatment. A study investigator will then phone the patient after
      14 days to see whether they are better or whether they required intravenous antibiotics to
      get better.
observational model: Cohort
time perspective: Prospective
measure: Treatment failure
time frame: 2 weeks post commencement of oral treatment
description: The primary outcome is the proportion of patients initially commenced on oral antibiotics who subsequently require IV antibiotics to achieve treatment response. This will be assessed by means of telephone follow-up performed at 14 days post enrolment into the study. Treatment failure is defined as attendance at a treating Emergency Department for intravenous antibiotic therapy if already commenced on oral therapy.
measure: Treatment failure - change in type or dose
time frame: 2 weeks
description: Treatment failure measured by change in prescribed oral antibiotic to another oral antibiotic.
Treatment failure measured by change in prescribed dose of oral antibiotic to a higher dose of the same antibiotic
measure: Inter-observer reliability for candidate predictor variables
time frame: At enrolment
description: Assessment of inter-observer reliability for the candidate predictor variables listed. This will be performed in at least 10% of patients enrolled into the study by a second recruiting clinician.
measure: Loss to follow up
time frame: 2 weeks
description: Assessment of the loss to follow-up rate and usefulness of the data collection proforma in the pilot study will also prove valuable for planning for the live study.
arm group label: Oral antibiotic therapy
description: Consecutive adult patients attending the study Emergency Departments with cellulitis will be considered eligible for recruitment to the study. Only those patients deemed suitable for oral antibiotic therapy and planned for discharge will be recruited to the study. Oral antibiotic therapy prescribed will be dependent on local institutional prescribing guidelines. For the purposes of the sites enrolling participants, the antibiotic of choice is oral flucloxacillin 500 milligrams four times daily for seven days. We will be assessing the treatment failure rate for this cohort of patients; namely, the number of patients requiring the primary outcome (change from oral to intravenous antibiotic therapy). We will also assess this group of patient for the secondary outcomes listed above.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Abel Wakai, MD FRCS FCEM
role: Principal Investigator
affiliation: Royal College of Surgeons, Ireland
facility: 
facility: 
facility: 
country: Ireland
responsible party type: Sponsor
mesh term: Cellulitis
mesh term: Emergencies
sharing ipd: Undecided