Evidence map›Paper›PMID 31815653›Full record

Trial reportTrials2019

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.

Maria Dudareva, Michelle Kümin, Werner Vach, Klaus Kaier, Jamie Ferguson, Martin McNally, Matthew Scarborough

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03806166 (Short or Long Antibiotic Regimes in Orthopaedics), which is not on this map. Cited by 43 papers.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03806166 nacompletednot on this map

Short or Long Antibiotic Regimes in Orthopaedics (SOLARIO): A Randomised Open Label Multi-Centre Clinical Trial

TypeinterventionalSponsorOxford University Hospitals NHS TrustRan2019 to 2025Enrolled500ConditionsOsteomyelitis, Prosthetic Joint Infection, Diabetic FootArmsShorter Systemic Antibiotics, Standard treatment
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 66 citations in OpenAlex.

  1. Short or Long Antibiotic Regimens in Orthopedics.The New England journal of medicine · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 4 institutions in 3 countries.

Maria DudarevaBone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK. maria.dudareva@ouh.nhs.uk.ORCID http://orcid.org/0000-0002-3139-7237
Michelle KüminNuffield Department of Medicine, University of Oxford, Oxford, UK.
Werner VachDepartment of Orthopaedics and Traumatology, Universitätsspital Basel, Basel, Switzerland.
Klaus KaierInstitute of Medical Biometry and Medical Informatics, Universitätsklinikums Freiburg, Freiburg, Germany.
Jamie FergusonBone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK.
Martin McNallyBone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK.
Matthew ScarboroughBone Infection Unit, Nuffield Orthopaedic Centre, Oxford University Hospitals, Oxford, UK.
Nuffield Orthopaedic Centre · GBUniversity Hospital of Basel · CHUniversity Medical Center Freiburg · DEUniversity of Oxford · GB

Funding

Department of Health NIHR300249NIHR Clinical Research Network Thames Valley and South Midlands Clinical Trials Fellowship
6 · The paper itself

Abstract

backgroundOrthopaedic 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.

methodsSOLARIO 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 registrationClinicaltrials.gov, NCT03806166. Registered on 11 November 2019.

Indexed as

AdultAnti-Bacterial AgentsBacterial InfectionsDiabetic FootHumansOsteomyelitisProsthesis-Related InfectionsAnti-Bacterial AgentsAntibioticCarrierDiabetic footDurationLocal antibiotic therapyOsteomyelitisProsthetic joint infectionRevision

Identifiers

PMID31815653
PMCPMC6902346
OpenAlexW2991719119

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.