<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/NCT03806166</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS No. 244229</org_study_id>
    <secondary_id>PID 13859</secondary_id>
    <nct_id>NCT03806166</nct_id>
  </id_info>
  <brief_title>Short or Long Antibiotic Regimes in Orthopaedics</brief_title>
  <acronym>SOLARIO</acronym>
  <official_title>Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oxford University Hospitals NHS Trust</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Research question: If adults with bone or joint infection have local antibiotic therapy, can&#xD;
      they do without prolonged treatment with antibiotics by mouth (oral) or injection?&#xD;
&#xD;
      Adults with bone or joint infections are usually given long courses of oral antibiotics or&#xD;
      into a vein (intravenous) following surgery. It is also safe to give antibiotics directly&#xD;
      into the bone or joint at the time of surgery: this is called local antibiotic therapy. This&#xD;
      study investigates whether using local antibiotic therapy would allow shorter courses of oral&#xD;
      or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost.&#xD;
&#xD;
      This study compares short against long courses of oral or intravenous antibiotics for adults&#xD;
      who have been given appropriate local antibiotic therapy to treat bone or joint infection.&#xD;
      Patients who can take part will be randomly divided into two groups within 7 days of surgery.&#xD;
      One group will stop oral or intravenous antibiotics, while the other group will continue for&#xD;
      4 weeks or more (standard treatment).&#xD;
&#xD;
      Adults with bone and joint infections who have already had surgery and local antibiotic&#xD;
      therapy will be invited. Patients will not take part if they need intravenous antibiotics for&#xD;
      another reason, or if their infection is caused by bacteria resistant to the antibiotic(s)&#xD;
      used in their local antibiotic therapy.&#xD;
&#xD;
      Main measurement: how many patients' infections return within 12 months after surgery. This&#xD;
      will be decided by a group of doctors who do not know what treatment the patient received.&#xD;
&#xD;
      Other important measurements: serious adverse events; side-effects; quality of life; cost of&#xD;
      treatment.&#xD;
&#xD;
      Patients will be asked questions at their usual clinic visits, and will be given a&#xD;
      questionnaire at the start of treatment and 1 year later.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using antibiotics wisely, only when and where they are really needed, is important to prevent&#xD;
      superbugs emerging. At the moment, bone and joint infections are usually treated by a&#xD;
      combination of surgery and antibiotics. Traditionally, treatment relies on several weeks of&#xD;
      antibiotics as tablets or injections (systemic antibiotics), but these can sometimes cause&#xD;
      problems.&#xD;
&#xD;
      It is now possible to administer local antibiotics at the time of surgery directly to the&#xD;
      site of infection. This allows much higher levels of the antibiotic to be delivered, for days&#xD;
      or weeks, following surgery. Therefore, this study will investigate whether local antibiotics&#xD;
      with a shorter course of systemic antibiotics can treat bone and joint infections as&#xD;
      effectively as local antibiotics with a prolonged course of systemic antibiotics (usual&#xD;
      treatment). If so, it may be possible to reduce antibiotic side effects, help to prevent&#xD;
      antibiotic resistant bacteria emerging and limit overall treatment costs.&#xD;
&#xD;
      Patients who agree to participate in this study will be allocated at random to two treatment&#xD;
      strategies after surgery for bone and joint infection.&#xD;
&#xD;
      One group of patients will be treated with local antibiotics and a long course of systemic&#xD;
      antibiotics, which is the usual treatment: this is the 'long group'.&#xD;
&#xD;
      The other group will be treated with local antibiotics and a short course of systemic&#xD;
      antibiotics: this is the 'short group' whose treatment differs from the current usual&#xD;
      treatment.&#xD;
&#xD;
      Patients will be involved in the study for one year, and infection recurrence will be&#xD;
      assessed at the time of routine clinic review up to 12 months after surgery. Whether or not&#xD;
      treatment has been successful will be assessed by an independent committee of specialists,&#xD;
      who will remain unaware of the patient's allocated treatment strategy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 21, 2019</start_date>
  <completion_date type="Anticipated">July 2024</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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>
    <intervention_model_description>Non-inferiority randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Ascertainment of the primary outcome (treatment failure) will be undertaken by an independent committee of specialists, using redacted participant clinical records, who will remain unaware of the treatment allocation of the participant, and who will ascertain treatment failure according to established objective criteria.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Definitive treatment failure (infection recurrence)</measure>
    <time_frame>12 months from the time of surgery for bone or joint infection</time_frame>
    <description>Proportion of participants in each treatment group experiencing definitive treatment failure (infection recurrence), ascertained by an independent committee of experts unaware of the treatment allocation of the participant, according to established criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Possible or probable treatment failure</measure>
    <time_frame>12 months from the time of surgery for bone or joint infection</time_frame>
    <description>Proportion of participants in each treatment group experiencing clinical features suggesting possible or probable infection recurrence, not meeting the definition for definitive treatment failure, determined by an independent committee of experts unaware of treatment allocation, where microbiological culture is not done or is negative. Ascertainment is based on established clinical criteria associated with, but not diagnostic of, orthopaedic infection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>12 months from the time of surgery for bone or joint infection</time_frame>
    <description>Proportion of participants in each treatment group experiencing Serious Adverse Events including mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibiotic side effects</measure>
    <time_frame>This will be assessed at baseline (pre-randomisation, at &lt;7 days of treatment), 6 weeks and 3 months from the time of surgery for bone or joint infection</time_frame>
    <description>Proportion of participants in each treatment group experiencing possible side-effects from systemic antibiotic treatment, adjusted for severity on a 3-point scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by EuroQol 5 Dimensions 5 Levels Score and EuroQol Visual Analogue Score</measure>
    <time_frame>At baseline and 12 months from the time of surgery for bone or joint infection</time_frame>
    <description>EQ-5D-5L score distribution across 5 dimensions (mobility, self-care, ability to complete usual activities, pain or discomfort, anxiety or depression) for participants, ranging from 1 (worst) to 5 (best) for each dimension. EQ-VAS score distribution for participants, for self-reported health state, ranging from 0 (worst) to 100 (best).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Osteomyelitis</condition>
  <condition>Prosthetic Joint Infection</condition>
  <condition>Diabetic Foot</condition>
  <arm_group>
    <arm_group_label>Shorter Systemic Antibiotics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive local antibiotic therapy at the time of surgery, followed by one week or less of systemic antibiotic therapy, for bone and joint infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Long Systemic Antibiotics</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive local antibiotic therapy at the time of surgery, followed by four weeks or more of systemic antibiotic therapy (standard treatment recommended by international guidelines), for bone and joint infection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Shorter Systemic Antibiotics</intervention_name>
    <description>Reduced duration of post-operative systemic antibiotic therapy</description>
    <arm_group_label>Shorter Systemic Antibiotics</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>Standard duration of systemic antibiotic treatment</description>
    <arm_group_label>Long Systemic Antibiotics</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent&#xD;
&#xD;
          2. Aged 18 years or over&#xD;
&#xD;
          3. Presenting with an orthopaedic infection, defined by one or more of the following&#xD;
             criteria:&#xD;
&#xD;
               1. localised pain, OR&#xD;
&#xD;
               2. localised erythema, OR&#xD;
&#xD;
               3. temperature ≥ 38.0 C, OR&#xD;
&#xD;
               4. a discharging sinus or wound&#xD;
&#xD;
          4. Undergoing surgical treatment for the infection&#xD;
&#xD;
          5. Locally administered antibiotic(s) at the site of orthopaedic infection&#xD;
&#xD;
          6. Has received &lt;= 7 days of systemic antimicrobial therapy after surgery&#xD;
&#xD;
          7. Would ordinarily be managed with a prolonged course (&gt;= 4 weeks) of systemic&#xD;
             antibiotic(s)&#xD;
&#xD;
          8. Specimens for microbiological analysis taken at index surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Surgical exclusion criteria&#xD;
&#xD;
          1. The index operation was not a definitive procedure with the aim of eradicating&#xD;
             infection:&#xD;
&#xD;
               1. Primary closure has not been achieved, or&#xD;
&#xD;
               2. Re-look surgery is planned&#xD;
&#xD;
          2. The index operation involved implant retention (e.g. DAIR)&#xD;
&#xD;
             Microbiological exclusion criteria&#xD;
&#xD;
          3. Any identified micro-organisms from operative specimens from the site of incident&#xD;
             infection are fully resistant to the local antibiotic(s) administered at the site of&#xD;
             infection&#xD;
&#xD;
             Medical exclusion criteria&#xD;
&#xD;
          4. Other infection necessitating additional systemic antibiotic treatment beyond 7 days&#xD;
             after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or&#xD;
             bacterial endocarditis&#xD;
&#xD;
          5. If the patient is in a clinical trial involving an Investigational Medicinal Product&#xD;
             (IMP) related to infection&#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_official>
    <last_name>Matthew Scarborough</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oxford University Hospitals</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr. Michelle Kumin</last_name>
    <phone>0300 3047777</phone>
    <email>maria.dudareva@ouh.nhs.uk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maria Dudareva</last_name>
    <phone>07791524686</phone>
    <email>maria.dudareva@ouh.nhs.uk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Universitaetsklinikum Regensburg</name>
      <address>
        <city>Regensburg</city>
        <zip>93053</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>49 941 9440</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital San Antonio</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>0300 304 7777</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Parc de Salut Mar</name>
      <address>
        <city>Barcelona</city>
        <zip>08003</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>34932483000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospitals Dorset</name>
      <address>
        <city>Poole</city>
        <state>Dorset</state>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01202 65511</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Southampton General Hospital</name>
      <address>
        <city>Southampton</city>
        <state>Hampshire</state>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>023 8077 7222</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Wrightington Hospital</name>
      <address>
        <city>Wigan</city>
        <state>Lancashire</state>
        <zip>WN6 9EP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Maria Dudareva</last_name>
      <phone>01942 244 000</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal National Orthopaedic Hospital</name>
      <address>
        <city>Stanmore</city>
        <state>London</state>
        <zip>HA7 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>The Robert Jones &amp; Agnes Hunt Hospital</name>
      <address>
        <city>Gobowen</city>
        <state>Oswestry</state>
        <zip>SY10 7AG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01691 404000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Bone Infection Unit, Nuffield Orthopaedic Centre</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7HE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Maria Dudareva</last_name>
      <phone>0300 304 7777</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
    <contact_backup>
      <last_name>Dr. Michelle Kumin</last_name>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Great Western Hospital</name>
      <address>
        <city>Swindon</city>
        <state>Wiltshire</state>
        <zip>SN3 6BB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01793 604020</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>0121 371 6800</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Blackpool Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Blackpool</city>
        <zip>FY3 8NR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Brighton &amp; Sussex University Hospitals NHS Trust</name>
      <address>
        <city>Brighton</city>
        <zip>BN2 5BE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01273 696955</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Royal Liverpool Hospitals</name>
      <address>
        <city>Liverpool</city>
        <zip>L7 8XP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Maria Dudareva</last_name>
      <phone>0151 706 2000</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Barts and the Royal London Hospitals</name>
      <address>
        <city>London</city>
        <zip>E1 1FR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>0207 7377 7000</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>London North West Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>HA1 3UJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W2 1NY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>020 3312 6666</phone>
      <email>maria.dudareva@ouh.nhs.uk</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Manchester University NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>0300 3309444</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northumbria Healthcare NHS Foundation Trust</name>
      <address>
        <city>Newcastle</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>0344 811 8111</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nottingham University Hospitals NHS Trust</name>
      <address>
        <city>Nottingham</city>
        <zip>NG5 1PB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>0115 969 1169</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Rotherham NHS Foundation Trust</name>
      <address>
        <city>Rotherham</city>
        <zip>S60 2UD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01709 820000</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Salisbury NHS Foundation Trust</name>
      <address>
        <city>Salisbury</city>
        <zip>SP2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01722 336262</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Mid Yorkshire Hospitals NHS Trust</name>
      <address>
        <city>Wakefield</city>
        <zip>WF1 4DG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Dudareva</last_name>
      <phone>01924 541000</phone>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>May 10, 2023</last_update_submitted>
  <last_update_submitted_qc>May 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oxford University Hospitals NHS Trust</investigator_affiliation>
    <investigator_full_name>Matthew Scarborough</investigator_full_name>
    <investigator_title>Principle Investigator, Consultant in Clinical Infection.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteomyelitis</mesh_term>
    <mesh_term>Diabetic Foot</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</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/NCT03806166
org study id: IRAS No. 244229
secondary id: PID 13859
nct id: NCT03806166
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Research question: If adults with bone or joint infection have local antibiotic therapy, can
      they do without prolonged treatment with antibiotics by mouth (oral) or injection?

      Adults with bone or joint infections are usually given long courses of oral antibiotics or
      into a vein (intravenous) following surgery. It is also safe to give antibiotics directly
      into the bone or joint at the time of surgery: this is called local antibiotic therapy. This
      study investigates whether using local antibiotic therapy would allow shorter courses of oral
      or intravenous antibiotics, in order to limit antibiotic resistance, side effects and cost.

      This study compares short against long courses of oral or intravenous antibiotics for adults
      who have been given appropriate local antibiotic therapy to treat bone or joint infection.
      Patients who can take part will be randomly divided into two groups within 7 days of surgery.
      One group will stop oral or intravenous antibiotics, while the other group will continue for
      4 weeks or more (standard treatment).

      Adults with bone and joint infections who have already had surgery and local antibiotic
      therapy will be invited. Patients will not take part if they need intravenous antibiotics for
      another reason, or if their infection is caused by bacteria resistant to the antibiotic(s)
      used in their local antibiotic therapy.

      Main measurement: how many patients' infections return within 12 months after surgery. This
      will be decided by a group of doctors who do not know what treatment the patient received.

      Other important measurements: serious adverse events; side-effects; quality of life; cost of
      treatment.

      Patients will be asked questions at their usual clinic visits, and will be given a
      questionnaire at the start of treatment and 1 year later.
Using antibiotics wisely, only when and where they are really needed, is important to prevent
      superbugs emerging. At the moment, bone and joint infections are usually treated by a
      combination of surgery and antibiotics. Traditionally, treatment relies on several weeks of
      antibiotics as tablets or injections (systemic antibiotics), but these can sometimes cause
      problems.

      It is now possible to administer local antibiotics at the time of surgery directly to the
      site of infection. This allows much higher levels of the antibiotic to be delivered, for days
      or weeks, following surgery. Therefore, this study will investigate whether local antibiotics
      with a shorter course of systemic antibiotics can treat bone and joint infections as
      effectively as local antibiotics with a prolonged course of systemic antibiotics (usual
      treatment). If so, it may be possible to reduce antibiotic side effects, help to prevent
      antibiotic resistant bacteria emerging and limit overall treatment costs.

      Patients who agree to participate in this study will be allocated at random to two treatment
      strategies after surgery for bone and joint infection.

      One group of patients will be treated with local antibiotics and a long course of systemic
      antibiotics, which is the usual treatment: this is the 'long group'.

      The other group will be treated with local antibiotics and a short course of systemic
      antibiotics: this is the 'short group' whose treatment differs from the current usual
      treatment.

      Patients will be involved in the study for one year, and infection recurrence will be
      assessed at the time of routine clinic review up to 12 months after surgery. Whether or not
      treatment has been successful will be assessed by an independent committee of specialists,
      who will remain unaware of the patient's allocated treatment strategy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Non-inferiority randomised controlled trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Ascertainment of the primary outcome (treatment failure) will be undertaken by an independent committee of specialists, using redacted participant clinical records, who will remain unaware of the treatment allocation of the participant, and who will ascertain treatment failure according to established objective criteria.
measure: Definitive treatment failure (infection recurrence)
time frame: 12 months from the time of surgery for bone or joint infection
description: Proportion of participants in each treatment group experiencing definitive treatment failure (infection recurrence), ascertained by an independent committee of experts unaware of the treatment allocation of the participant, according to established criteria.
measure: Possible or probable treatment failure
time frame: 12 months from the time of surgery for bone or joint infection
description: Proportion of participants in each treatment group experiencing clinical features suggesting possible or probable infection recurrence, not meeting the definition for definitive treatment failure, determined by an independent committee of experts unaware of treatment allocation, where microbiological culture is not done or is negative. Ascertainment is based on established clinical criteria associated with, but not diagnostic of, orthopaedic infection.
measure: Serious Adverse Events
time frame: 12 months from the time of surgery for bone or joint infection
description: Proportion of participants in each treatment group experiencing Serious Adverse Events including mortality
measure: Antibiotic side effects
time frame: This will be assessed at baseline (pre-randomisation, at <7 days of treatment), 6 weeks and 3 months from the time of surgery for bone or joint infection
description: Proportion of participants in each treatment group experiencing possible side-effects from systemic antibiotic treatment, adjusted for severity on a 3-point scale
measure: Quality of life measured by EuroQol 5 Dimensions 5 Levels Score and EuroQol Visual Analogue Score
time frame: At baseline and 12 months from the time of surgery for bone or joint infection
description: EQ-5D-5L score distribution across 5 dimensions (mobility, self-care, ability to complete usual activities, pain or discomfort, anxiety or depression) for participants, ranging from 1 (worst) to 5 (best) for each dimension. EQ-VAS score distribution for participants, for self-reported health state, ranging from 0 (worst) to 100 (best).
arm group label: Shorter Systemic Antibiotics
arm group type: Experimental
description: Participants will receive local antibiotic therapy at the time of surgery, followed by one week or less of systemic antibiotic therapy, for bone and joint infection.
arm group label: Long Systemic Antibiotics
arm group type: Active Comparator
description: Participants will receive local antibiotic therapy at the time of surgery, followed by four weeks or more of systemic antibiotic therapy (standard treatment recommended by international guidelines), for bone and joint infection.
intervention type: Other
intervention name: Shorter Systemic Antibiotics
description: Reduced duration of post-operative systemic antibiotic therapy
arm group label: Shorter Systemic Antibiotics
intervention type: Other
intervention name: Standard treatment
description: Standard duration of systemic antibiotic treatment
arm group label: Long Systemic Antibiotics
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Scarborough
role: Principal Investigator
affiliation: Oxford University Hospitals
last name: Dr. Michelle Kumin
phone: 0300 3047777
email: maria.dudareva@ouh.nhs.uk
last name: Maria Dudareva
phone: 07791524686
email: maria.dudareva@ouh.nhs.uk
facility: 
status: Recruiting
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contact: 
country: Germany
country: Portugal
country: Spain
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Oxford University Hospitals NHS Trust
investigator full name: Matthew Scarborough
investigator title: Principle Investigator, Consultant in Clinical Infection.
mesh term: Osteomyelitis
mesh term: Diabetic Foot
mesh term: Anti-Bacterial Agents
sharing ipd: No