OsteomyelitisSOLARIONCT03806166
Short or Long Antibiotic Regimes in Orthopaedics
A study testing Shorter Systemic Antibiotics and Standard treatment in people with Osteomyelitis and Prosthetic Joint Infection, run by Oxford University Hospitals NHS Trust at 23 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteomyelitis, Prosthetic Joint Infection, Diabetic Foot
- What is being tested?
- Shorter Systemic Antibiotics and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 23 sitesin 4 countries
- Study dates
- 21 Feb 2019to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- Surgical exclusion criteria
- 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)
- Microbiological exclusion criteria
Show all 10Show fewer
- 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
- 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
Trial locations and contacts
23 sites in 4 countries.
23 sites in 4 countries
United Kingdom20 sites
University Hospitals Birmingham
Birmingham
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, FY3 8NR
Brighton & Sussex University Hospitals NHS Trust
Brighton, BN2 5BE
The Robert Jones & Agnes Hunt Hospital
Gobowen, Oswestry, SY10 7AG
Royal Liverpool Hospitals
Liverpool, L7 8XP
Barts and the Royal London Hospitals
London, London, E1 1FR
London North West Healthcare NHS Trust
London, HA1 3UJ
Imperial College Healthcare NHS Trust
London, W2 1NY
Manchester University NHS Foundation Trust
Manchester, M13 9WL
Northumbria Healthcare NHS Foundation Trust
Newcastle
Nottingham University Hospitals NHS Trust
Nottingham, NG5 1PB
Bone Infection Unit, Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7HE
University Hospitals Dorset
Poole, Dorset, BH15 2JB
The Rotherham NHS Foundation Trust
Rotherham, S60 2UD
Salisbury NHS Foundation Trust
Salisbury, SP2 8BJ
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Royal National Orthopaedic Hospital
Stanmore, London, HA7 4LP
Great Western Hospital
Swindon, Wiltshire, SN3 6BB
The Mid Yorkshire Hospitals NHS Trust
Wakefield, WF1 4DG
Wrightington Hospital
Wigan, Lancashire, WN6 9EP
About this study
Official title: Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
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.
Read more
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.
Read the 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.
- Conditions
- Osteomyelitis, Prosthetic Joint Infection, Diabetic Foot
- Being tested
- Shorter Systemic Antibiotics, Standard treatment
- Medical subject headings
- Osteomyelitis, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shorter Systemic AntibioticsOther
Reduced duration of post-operative systemic antibiotic therapy
Standard treatmentOther
Standard duration of systemic antibiotic treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months from the time of surgery for bone or joint infection
Secondary outcomes (4)
Possible or probable treatment failure
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.
Measured: 12 months from the time of surgery for bone or joint infection
Serious Adverse Events
Proportion of participants in each treatment group experiencing Serious Adverse Events including mortality
Measured: 12 months from the time of surgery for bone or joint infection
Antibiotic side effects
Proportion of participants in each treatment group experiencing possible side-effects from systemic antibiotic treatment, adjusted for severity on a 3-point scale
Measured: 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
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).
Measured: At baseline and 12 months from the time of surgery for bone or joint infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start21 Feb 2019
- Primary completion4 Dec 2024
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Scarborough, Oxford University Hospitals NHS Trust
- Investigators
- Matthew Scarborough, Principal investigator, Oxford University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806166
- Sponsor's protocol ID
- IRAS No. 244229
- Other IDs
- PID 13859
- Acronym
- SOLARIO
- Status last verified
- Dec 2024
- First submitted
- 11 Jan 2019
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McNally M, Dudareva M, Kumin M, Vach W, Scarborough CL, Cichero MJ, Sousa R, Ferguson J, Stubbs DA, Atkins BL, Ramsden AJ, Young BC, Carvalho AD, Kendal AR, Alvand A, Palmer AJR, Loizou CL, Kendrick B, Taylor AH, Islam A, Riste MJ, Pillai A, Sharma SK, Folb J, Jacobs N, Ellis SC, Ng ABY, Perez-Prieto D, Sigmund IK, Windhager R, Iliadis AD, Bing AJF, Wynn Jones H, Williams J, Ollivere BJ, Alt V, Warren S, Jenkins NE, Leithner A, Hughes HC, Jones SA, Williams OM, Scarborough M. Short or Long Antibiotic Regimens in Orthopedics. N Engl J Med. 2026 Sep 16. doi: 10.1056/NEJMoa2506756. Online ahead of print.
PubMed 42748421Dudareva 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.
PubMed 31815653
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial
- ClinicalTrials.gov ID
- NCT03806166
- Acronym / sponsor ID
- SOLARIO / IRAS No. 244229
- Conditions
- Osteomyelitis, Prosthetic Joint Infection, Diabetic Foot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 16 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Non-inferiority randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Shorter Systemic Antibiotics | Experimental | Other: Shorter Systemic AntibioticsParticipants 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. |
| Long Systemic Antibiotics | Active comparator | Other: Standard treatmentParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provision of informed consent
- Aged 18 years or over
- Presenting with an orthopaedic infection, defined by one or more of the following criteria:
- Undergoing surgical treatment for the infection
- Locally administered antibiotic(s) at the site of orthopaedic infection
Key exclusion criteria (10 listed)
- Surgical exclusion criteria
- The index operation was not a definitive procedure with the aim of eradicating infection:
- The index operation involved implant retention (e.g. DAIR)
- Microbiological exclusion criteria
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shorter Systemic AntibioticsReduced duration of post-operative systemic antibiotic therapy | Other | Shorter Systemic Antibiotics |
| Standard treatmentStandard duration of systemic antibiotic treatment | Other | Long Systemic Antibiotics |
Primary outcome
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.
4 secondary outcomes
Possible or probable treatment failure
Time frame: 12 months from the time of surgery for bone or joint infection
Serious Adverse Events
Time frame: 12 months from the time of surgery for bone or joint infection
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Derived from this study: PubMed 42748421McNally M, Dudareva M, Kumin M, Vach W, Scarborough CL, Cichero MJ, Sousa R, Ferguson J, Stubbs DA, Atkins BL, Ramsden AJ, Young BC, Carvalho AD, Kendal AR, Alvand A, Palmer AJR, Loizou CL, Kendrick B, Taylor AH, Islam A, Riste MJ, Pillai A, Sharma SK, Folb J, Jacobs N, Ellis SC, Ng ABY, Perez-Prieto D, Sigmund IK, Windhager R, Iliadis AD, Bing AJF, Wynn Jones H, Williams J, Ollivere BJ, Alt V, Warren S, Jenkins NE, Leithner A, Hughes HC, Jones SA, Williams OM, Scarborough M. Short or Long Antibiotic Regimens in Orthopedics. N Engl J Med. 2026 Sep 16. doi: 10.1056/NEJMoa2506756. Online ahead of print.
- Derived from this study: PubMed 31815653Dudareva 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Scarborough principal investigator
Oxford University Hospitals
23 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shorter Systemic Antibiotics and Standard treatment in people with Osteomyelitis and Prosthetic Joint Infection, run by Oxford University Hospitals NHS Trust at 23 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United Kingdom, Germany, Portugal, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Definitive treatment failure (infection recurrence) (time frame: 12 months from the time of surgery for bone or joint infection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806166, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.