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

Oxford University Hospitals NHS Foundation Trust0 个研究点目标入组 20 人开始时间: 2022年4月18日最近更新: 2022年8月8日

适应症

试验速览

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•1)Provision of informed consent
•2)Aged 18 years or over
•3)Presenting with an orthopaedic infection, defined by one or more of the following criteria:
•a) localised pain, OR
•b) localised erythema, OR
•c) temperature = 38.0ºC, OR
•d) a discharging sinus or wound
•4)Undergoing surgical treatment for the infection
•5)Locally administered antibiotics in a HTA-approved product or in a carrier CE marked for antibiotic delivery
•6)Has received <= 7 days of systemic antimicrobial therapy after surgery
•7)Would ordinarily be managed with a prolonged course (>= 4 weeks) of systemic antibiotic(s)
•8)Specimens for microbiological analysis taken at index surgery
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Surgical exclusion criteria
•1) The index operation was not a definitive procedure with the aim of eradicating infection:
•a) Primary closure has not been achieved, or
•b) Re-look surgery is planned
•2) The index operation involved implant retention (e.g. DAIR)
•Microbiological exclusion criteria
•3) 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
•4) Other infection necessitating additional systemic antibiotic treatment beyond 7 days after surgery, such as Staphylococcus aureus bacteraemia, psoas abscess, discitis or bacterial endocarditis.
•5) If the patient is in a clinical trial involving an Investigational Medicinal Product (IMP) related to infection

发起方

Oxford University Hospitals NHS Foundation Trust