Short or Long Antibiotic Regimes in Orthopaedics

NCT03806166 | Completed DMC

• 2 other identifiers: IRAS No. 244229PID 13859
• Study Type: interventional
• Target: 500
• Locations: 4 countries
• Sites: 23

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.

Conditions

Osteomyelitis; Prosthetic Joint Infection; Diabetic Foot

Outcome Measures

Primary Outcomes (1)

• Definitive treatment failure (infection recurrence)

  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.

  12 months from the time of surgery for bone or joint infection

Secondary Outcomes (4)

• Possible or probable treatment failure

  12 months from the time of surgery for bone or joint infection

• Serious Adverse Events

  12 months from the time of surgery for bone or joint infection

• Antibiotic side effects

  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

• Quality of life measured by EuroQol 5 Dimensions 5 Levels Score and EuroQol Visual Analogue Score

  At baseline and 12 months from the time of surgery for bone or joint infection

Study Arms (2)

Shorter Systemic Antibiotics

EXPERIMENTAL

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

Long Systemic Antibiotics

ACTIVE COMPARATOR

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

Interventions

Shorter Systemic Antibiotics OTHER

Reduced duration of post-operative systemic antibiotic therapy

Shorter Systemic Antibiotics

Standard treatment OTHER

Standard duration of systemic antibiotic treatment

Long Systemic Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of informed consent
• Aged 18 years or over
• Presenting with an orthopaedic infection, defined by one or more of the following criteria:
• localised pain, OR
• localised erythema, OR
• temperature ≥ 38.0 C, OR
• a discharging sinus or wound
• Undergoing surgical treatment for the infection
• Locally administered antibiotic(s) at the site of orthopaedic infection
• Has received \<= 7 days of systemic antimicrobial therapy after surgery
• Would ordinarily be managed with a prolonged course (\>= 4 weeks) of systemic antibiotic(s)
• Specimens for microbiological analysis taken at index surgery

You may not qualify if:

• The index operation was not a definitive procedure with the aim of eradicating infection:
• Primary closure has not been achieved, or
• Re-look surgery is planned
• The index operation involved implant retention (e.g. DAIR)
• 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
• Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis
• If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead

Study Sites (23)

Universitaetsklinikum Regensburg

Regensburg, 93053, Germany

Location

Hospital San Antonio

Porto, Portugal

Location

Parc de Salut Mar

Barcelona, 08003, Spain

Location

University Hospitals Dorset

Poole, Dorset, BH15 2JB, United Kingdom

Location

Southampton General Hospital

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Wrightington Hospital

Wigan, Lancashire, WN6 9EP, United Kingdom

Location

Barts and the Royal London Hospitals

London, London, E1 1FR, United Kingdom

Location

Royal National Orthopaedic Hospital

Stanmore, London, HA7 4LP, United Kingdom

Location

The Robert Jones & Agnes Hunt Hospital

Gobowen, Oswestry, SY10 7AG, United Kingdom

Location

Bone Infection Unit, Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

Great Western Hospital

Swindon, Wiltshire, SN3 6BB, United Kingdom

Location

University Hospitals Birmingham

Birmingham, United Kingdom

Location

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, FY3 8NR, United Kingdom

Location

Brighton & Sussex University Hospitals NHS Trust

Brighton, BN2 5BE, United Kingdom

Location

Royal Liverpool Hospitals

Liverpool, L7 8XP, United Kingdom

Location

London North West Healthcare NHS Trust

London, HA1 3UJ, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Northumbria Healthcare NHS Foundation Trust

Newcastle, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

The Rotherham NHS Foundation Trust

Rotherham, S60 2UD, United Kingdom

Location

Salisbury NHS Foundation Trust

Salisbury, SP2 8BJ, United Kingdom

Location

The Mid Yorkshire Hospitals NHS Trust

Wakefield, WF1 4DG, United Kingdom

Location

Related Publications (1)

• Dudareva M, Kumin M, Vach W, Kaier K, Ferguson J, McNally M, Scarborough M. Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): a randomised controlled open-label non-inferiority trial of duration of systemic antibiotics in adults with orthopaedic infection treated operatively with local antibiotic therapy. Trials. 2019 Dec 9;20(1):693. doi: 10.1186/s13063-019-3832-3.

  PMID: 31815653 DERIVED

MeSH Terms

Conditions

Osteomyelitis; Diabetic Foot

Condition Hierarchy (Ancestors)

Bone Diseases, Infectious; Infections; Bone Diseases; Musculoskeletal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Matthew Scarborough

  Oxford University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator, Consultant in Clinical Infection.

Model Details: Non-inferiority randomised controlled trial

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 16, 2019
• Study Start: February 21, 2019
• Primary Completion: December 4, 2024
• Study Completion: January 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); ES (1); GB (20); PT (1)