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Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO)

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ClinicalTrials.gov Identifier: NCT03806166
Recruitment Status : Recruiting
First Posted : January 16, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Matthew Scarborough, Oxford University Hospitals NHS Trust

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteomyelitis Prosthetic Joint Infection Diabetic Foot Other: Shorter Systemic Antibiotics Other: Standard treatment Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-inferiority randomised controlled trial
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.
Primary Purpose: Treatment
Official Title: Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
Actual Study Start Date : February 21, 2019
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Experimental: Shorter Systemic Antibiotics
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.
Other: Shorter Systemic Antibiotics
Reduced duration of post-operative systemic antibiotic therapy

Active Comparator: Long Systemic Antibiotics
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.
Other: Standard treatment
Standard duration of systemic antibiotic treatment




Primary Outcome Measures :
  1. Definitive treatment failure (infection recurrence) [ Time Frame: 12 months from the time of surgery for bone or joint infection ]
    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.


Secondary Outcome Measures :
  1. Possible or probable treatment failure [ Time Frame: 12 months from the time of surgery for bone or joint infection ]
    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.

  2. Serious Adverse Events [ Time Frame: 12 months from the time of surgery for bone or joint infection ]
    Proportion of participants in each treatment group experiencing Serious Adverse Events including mortality

  3. 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 ]
    Proportion of participants in each treatment group experiencing possible side-effects from systemic antibiotic treatment, adjusted for severity on a 3-point scale

  4. 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 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provision of informed consent
  2. Aged 18 years or over
  3. Presenting with an orthopaedic infection, defined by one or more of the following criteria:

    1. localised pain, OR
    2. localised erythema, OR
    3. temperature ≥ 38.0 C, OR
    4. a discharging sinus or wound
  4. Undergoing surgical treatment for the infection
  5. Locally administered antibiotic(s) at the site of orthopaedic infection
  6. Has received <= 7 days of systemic antimicrobial therapy after surgery
  7. Would ordinarily be managed with a prolonged course (>= 4 weeks) of systemic antibiotic(s)
  8. Specimens for microbiological analysis taken at index surgery

Exclusion Criteria:

Surgical exclusion criteria

  1. The index operation was not a definitive procedure with the aim of eradicating infection:

    1. Primary closure has not been achieved, or
    2. Re-look surgery is planned
  2. The index operation involved implant retention (e.g. DAIR)

    Microbiological exclusion criteria

  3. Any identified micro-organisms from operative specimens from the site of incident infection are fully resistant to the local antibiotic(s) administered at the site of infection

    Medical exclusion criteria

  4. Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis
  5. If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806166


Contacts
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Contact: Dr. Michelle Kumin 0300 3047777 maria.dudareva@ouh.nhs.uk

Locations
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Portugal
Hospital San Antonio Recruiting
Porto, Portugal
Contact: Maria Dudareva    0300 304 7777      
United Kingdom
Wrightington Hospital Recruiting
Wigan, Lancashire, United Kingdom, WN6 9EP
Contact: Dr. Maria Dudareva    01942 244 000    maria.dudareva@ouh.nhs.uk   
Royal National Orthopaedic Hospital Recruiting
Stanmore, London, United Kingdom, HA7 4LP
Contact: Dr. Maria Dudareva    0203 947 0100    maria.dudareva@ouh.nhs.uk   
Bone Infection Unit, Nuffield Orthopaedic Centre Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 7HE
Contact: Dr. Maria Dudareva    0300 304 7777    maria.dudareva@ouh.nhs.uk   
Contact: Dr. Michelle Kumin         
Great Western Hospital Recruiting
Swindon, Wiltshire, United Kingdom, SN3 6BB
Contact: Maria Dudareva    01793 604020    maria.dudareva@ouh.nhs.uk   
University Hospitals Birmingham Recruiting
Birmingham, United Kingdom
Contact: Maria Dudareva    0121 371 6800      
Royal Liverpool Hospitals Recruiting
Liverpool, United Kingdom, L7 8XP
Contact: Dr. Maria Dudareva    0151 706 2000    maria.dudareva@ouh.nhs.uk   
Northumbria Healthcare NHS Foundation Trust Recruiting
Newcastle, United Kingdom
Contact: Maria Dudareva    0344 811 8111      
Sponsors and Collaborators
Oxford University Hospitals NHS Trust

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Responsible Party: Matthew Scarborough, Principle Investigator, Consultant in Clinical Infection., Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03806166     History of Changes
Other Study ID Numbers: IRAS No. 244229
PID 13859 ( Other Identifier: Oxford University Hospitals NHS Foundation Trust )
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Osteomyelitis
Diabetic Foot
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases