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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|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.|
|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|
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
- 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.
- 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.
- 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
- 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
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806166
|Contact: Dr. Michelle Kumin||0300 firstname.lastname@example.org|
|Hospital San Antonio||Recruiting|
|Contact: Maria Dudareva 0300 304 7777|
|Wigan, Lancashire, United Kingdom, WN6 9EP|
|Contact: Dr. Maria Dudareva 01942 244 000 email@example.com|
|Royal National Orthopaedic Hospital||Recruiting|
|Stanmore, London, United Kingdom, HA7 4LP|
|Contact: Dr. Maria Dudareva 0203 947 0100 firstname.lastname@example.org|
|Bone Infection Unit, Nuffield Orthopaedic Centre||Recruiting|
|Oxford, Oxfordshire, United Kingdom, OX3 7HE|
|Contact: Dr. Maria Dudareva 0300 304 7777 email@example.com|
|Contact: Dr. Michelle Kumin|
|Great Western Hospital||Recruiting|
|Swindon, Wiltshire, United Kingdom, SN3 6BB|
|Contact: Maria Dudareva 01793 604020 firstname.lastname@example.org|
|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 email@example.com|
|Northumbria Healthcare NHS Foundation Trust||Recruiting|
|Newcastle, United Kingdom|
|Contact: Maria Dudareva 0344 811 8111|