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

Abstract Background Orthopaedic infections, such as osteomyelitis, diabetic foot infection and prosthetic joint infection, are most commonly treated by a combination of surgical debridement and a prolonged course of systemic antibiotics, usually for at least 4–6 weeks. Use of local antibiotics, implanted directly into the site of infection at the time of surgery, may improve antibiotic delivery and allow us to shorten the duration of systemic antibiotic therapy, thereby limiting the frequency of side effects, cost and selection pressure for antimicrobial resistance. Methods SOLARIO is a multicentre open-label randomised controlled non-inferiority trial comparing short and long systemic antibiotic therapy alongside local antibiotic therapy. Adult patients with orthopaedic infection, who have given informed consent, will be eligible to participate in the study provided that no micro-organisms identified from deep tissue samples are resistant to locally implanted antibiotics. Participants will be randomised in a 1:1 ratio to receive either a short course (≤ 7 days) or currently recommended long course (≥ 4 weeks) of systemic antibiotics. The primary outcome will be treatment failure by 12 months after surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation. An absolute non-inferiority margin of 10% will be used for both per-protocol and intention-to-treat populations. Secondary outcomes will include probable and definite treatment failure, serious adverse events, treatment side effects, quality of life scores and cost analysis. Discussion This study aims to assess a treatment strategy that may enable the reduction of systemic antibiotic use for patients with orthopaedic infection. If this strategy is non-inferior, this will be to the advantage of patients and contribute to antimicrobial stewardship. Trial registration Clinicaltrials.gov, NCT03806166. Registered on 11 November 2019.

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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

10.21203/rs.2.13884/v1 ◽

2019 ◽

Author(s):

Maria Dudareva ◽

Michelle Kümin ◽

Werner Vach ◽

Klaus Kaier ◽

Jamie Ferguson ◽

...

Keyword(s):

Side Effects ◽

Antibiotic Therapy ◽

Treatment Failure ◽

Open Label ◽

Systemic Antibiotic ◽

Systemic Antibiotic Therapy ◽

Randomised Controlled ◽

Systemic Antibiotics ◽

Local Antibiotic ◽

Local Antibiotic Therapy

Abstract Background Orthopaedic infections such as osteomyelitis, diabetic foot infection and prosthetic joint infection, are most commonly treated by a combination of surgical debridement and a prolonged course of systemic antibiotics, usually for at least 4 -6 weeks. Use of local antibiotics, implanted directly into the site of infection at the time of surgery, may improve antibiotic delivery and allow us to shorten the duration of systemic antibiotic therapy, thereby limiting the frequency of side effects, cost and selection pressure for antimicrobial resistance. Methods SOLARIO is a multi-centre open label randomised controlled non-inferiority trial comparing short and long systemic antibiotic therapy alongside local antibiotic therapy. Adult patients with orthopaedic infection, who have given informed consent, will be eligible to participate in the study provided that no micro-organisms identified from deep tissue samples are resistant to locally-implanted antibiotics. Participants will be randomised in a 1:1 ratio to receive either a short course (≤ 7 days) or currently recommended long course (≥ 4 weeks) of systemic antibiotics. The primary outcome will be treatment failure by 12 months following surgery, as ascertained by an independent Endpoint Committee blinded to treatment allocation. An absolute non-inferiority margin of 10% will be used for both per-protocol and intention-to-treat populations. Secondary outcomes will include probable and definite treatment failure, serious adverse events, treatment side-effects, quality of life scores and cost analysis. Discussion This study aims to assess a treatment strategy that may enable the reduction of systemic antibiotic use for patients with orthopaedic infection. If effective, this will be to the advantage of patients and contribute to antimicrobial stewardship.

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Abscesses of the breast: US-guided serial percutaneous aspiration and local antibiotic therapy after unsuccessful systemic antibiotic therapy

Acta Radiologica ◽

10.1080/028418501127346666 ◽

2001 ◽

Vol 42 (2) ◽

pp. 161-165 ◽

Cited By ~ 1

Author(s):

A. Imperiale ◽

F. Zandrino ◽

M. Calabrese ◽

G. Parodi ◽

T. Massa

Keyword(s):

Antibiotic Therapy ◽

Percutaneous Aspiration ◽

Systemic Antibiotic ◽

Systemic Antibiotic Therapy ◽

Local Antibiotic ◽

Local Antibiotic Therapy

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ABSCESSES OF THE BREAST. US-guided serial percutaneous aspiration and local antibiotic therapy after unsuccessful systemic antibiotic therapy

Acta Radiologica ◽

10.1034/j.1600-0455.2001.042002161.x ◽

2001 ◽

Vol 42 (2) ◽

pp. 161-165 ◽

Cited By ~ 3

Author(s):

A. Imperiale ◽

F. Zandrino ◽

M. Calabrese ◽

G. Parodi ◽

T. Massa

Keyword(s):

Antibiotic Therapy ◽

Percutaneous Aspiration ◽

Systemic Antibiotic ◽

Systemic Antibiotic Therapy ◽

Local Antibiotic ◽

Local Antibiotic Therapy

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Development and application of antibiotic-loaded bone cement beads

Journal of the American Podiatric Medical Association ◽

10.7547/87507315-80-7-354 ◽

1990 ◽

Vol 80 (7) ◽

pp. 354-359 ◽

Cited By ~ 14

Author(s):

DE Stabile ◽

AM Jacobs

Keyword(s):

Soft Tissue ◽

Antibiotic Therapy ◽

Bone Cement ◽

Clinical Judgment ◽

Soft Tissue Infections ◽

Systemic Antibiotic ◽

Systemic Antibiotic Therapy ◽

Local Antibiotic ◽

Vascular Status ◽

Causes Of Failure

The authors presented an overview of the development of antibiotic-loaded bone cement beads and their indications for usage, method of application, advantages, disadvantages, and causes of failure. This method of treatment for bone and soft tissue infections of the foot is not a panacea and should be used only in selected cases. The vascular status and the physiologic ability of the patient to heal a peripheral wound or infection are the basis for the success of this method of therapy. European literature makes little mention of adjunctive systemic antibiotic therapy with local antibiotic-loaded bone cement bead use. It is the authors' opinion that clinical judgment should be used to determine the necessity for such therapy.

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Significant reduction in stereotactic and functional neurosurgical hardware infection after local neomycin/polymyxin application

Journal of Neurosurgery ◽

10.3171/2008.6.17605 ◽

2009 ◽

Vol 110 (2) ◽

pp. 247-250 ◽

Cited By ~ 33

Author(s):

Jonathan P. Miller ◽

Feridun Acar ◽

Kim J. Burchiel

Keyword(s):

Antibiotic Prophylaxis ◽

Infection Rate ◽

Polymyxin B ◽

Primary Outcome Measure ◽

Local Antibiotics ◽

Systemic Antibiotic ◽

Systemic Antibiotic Therapy ◽

Intravenous Antibiotics ◽

Systemic Antibiotics ◽

Local Antibiotic

Object Hardware infection is a common occurrence after the implantation of neurostimulation and intrathecal drug delivery devices. The authors investigated whether the application of a neomycin/polymyxin solution directly into the surgical wound decreases the incidence of perioperative infection. Methods Data from all stereotactic and functional hardware procedures performed at the Oregon Health & Science University over a 5-year period were reviewed. All patients received systemic antibiotic prophylaxis. For the last 18 months of the 5-year period, wounds were additionally injected with a solution consisting of 40 mg neomycin and 200,000 U polymyxin B sulfate diluted in 10 ml normal saline. The primary outcome measure was infection of the hardware requiring explantation. Results Six hundred fourteen patients underwent hardware implantation. Among 455 patients receiving only intravenous antibiotics, the infection rate was 5.7%. Only 2 (1.2%) of 159 patients receiving both intravenous and local antibiotics had an infection. The wounds in both of these patients were compromised postoperatively: 1 patient had entered a swimming pool, and the other had undergone a general surgery procedure that exposed the hardware. If these patients are excluded from analysis, the effective infection rate using a combined intravenous and local antibiotic prophylaxis is 0%. There were no complications due to toxicity. Conclusions The combination of local neomycin/polymyxin with systemic antibiotic therapy can lead to a significantly lower rate of postoperative infection than when systemic antibiotics are used alone.

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