2026-526270-17-00招募中4 期
Early switch to oral antibiotic therapy in vertebral osteomyelitis: a multicentre, open-label, randomised, active control, parallel group, non-inferiority trial (sWITCH-VO)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 13
- 主要终点
- Composite clinical failure endpoint assessed 24 weeks after cessation of antibiotic therapy, including: - All-cause mortality - Unplanned spine-related surgery for VO - Relapse of bacteraemia with the primary pathogen - Relapse of bacteria with the initial pathogen being cultured from material from infected areas in relation to the spine or iliopsoas muscle - Renewed IV antibiotic therapy for >7 days for treatment of VO
研究概览
简要总结
To demonstrate the non-inferiority of an early switch from intravenous (IV) to oral antibiotic therapy after 7 days compared to a switch after 14 days in patients with pyogenic Vertebral Osteomyelitis (VO).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Signed and dated written informed consent prior to any study-related procedures
- •VO, diagnosed by the clinician in charge and confirmed by an ID specialist based on clinical symptoms, findings consistent with VO and characteristic radiological features (MRI, PET/CT or PET/MRI)
- •The physician responsible for the patient and the ID consultant decide to treat the patient for VO
- •At the time of randomisation CRP has decreased to < 75% of peak value or < 20 mg/l
- •The patient has received appropriate IV antibiotic therapy for VO for a maximum of 7 days at the time of randomisation (if a surgical intervention for infection control is performed after starting IV therapy, day 1 is counted as the first dose of appropriate IV antibiotics given after surgery)
- •An ID treatment recommendation regarding the IV and oral antibiotic therapy as well as treatment duration is available
- •ID treatment recommendation for oral antibiotic according to the “list of antibiotics”
排除标准
- •Identification of Actinomyces, Nocardia, fungal, brucellar or mycobacterial infection
- •The patient is unlikely to adhere to the trial requirements after enrolment according to the investigator’s opinion
- •Participation in any other interventional clinical trial within the last 30 days before the start of this trial
- •The patient is unable to understand the nature and consequences of the trial
- •Life expectancy < 6 months
- •Patients with any kind of dependency on the investigator or employed by the sponsor or investigator
- •Patients held in an institution by legal or official order
- •Female patients with childbearing potential. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy
- •Patients not capable of providing informed consent at time of screening for inclusion
- •Identification of Pseudomonas aeruginosa in patients with spinal foreign material
- •Previous episodes of VO within the past 24 months
- •Suspected or proven bacterial endocarditis (there are no study mandated investigations e.g. echocardiography or other investigations to exclude endocarditis in the absence of a clinical indication)
- •Severe immunocompromise defined as transplant recipients, patients having hematological malignancies currently undergoing or having undergone active medical treatment within the last six months, patients having solid organ cancers currently undergoing immunosuppressive treatment, or at a current risk of febrile neutropenia and patients having received an IL6 inhibitor within the last 3 months
- •Any signs or symptoms of uncontrolled infection or other concomitant or unrelated infections that require to extend IV antibiotic therapy beyond 7 days of duration at the time of randomisation as recommended by the ID specialist or clinician in charge
- •Clinical factors (e.g. reduced gastrointestinal absorption, inability to take oral drugs, expected toxicity) which do not allow oral treatment as defined by the clinician in charge or an ID specialist
- •Persistent S. aureus bacteremia (defined as blood-culture taken >48 hours after initiation of appropriate therapy)
- •No reasonable oral treatment options to permit enrolment (e.g. underlying pathogen is only sensitive to IV antibiotics, underlying pathogen is only sensitive to oral antibiotics with poor bioavailability or poor efficacy according to current studies and clinical experience) as defined by an ID specialist and judged by the principal investigator
结局指标
主要结局
Composite clinical failure endpoint assessed 24 weeks after cessation of antibiotic therapy, including: - All-cause mortality - Unplanned spine-related surgery for VO - Relapse of bacteraemia with the primary pathogen - Relapse of bacteria with the initial pathogen being cultured from material from infected areas in relation to the spine or iliopsoas muscle - Renewed IV antibiotic therapy for >7 days for treatment of VO
Composite clinical failure endpoint assessed 24 weeks after cessation of antibiotic therapy, including: - All-cause mortality - Unplanned spine-related surgery for VO - Relapse of bacteraemia with the primary pathogen - Relapse of bacteria with the initial pathogen being cultured from material from infected areas in relation to the spine or iliopsoas muscle - Renewed IV antibiotic therapy for >7 days for treatment of VO
次要结局
- Quality of life, measured by patient-reported outcome measures (PROMs) using the Oswestry Disability Index (ODI)
- Occurrence of each component of the composite primary endpoint
- Duration of hospital stay
- Occurrence of readmission
- Early termination of allocated treatment strategy due to adverse events, patient preference, or any other reason
- Complications related to IV treatment
- Incidence of Clostridioides difficile–associated diarrhoea
- Quality of life measured by EQ-5D-5L
- Functional status and activities of daily living (CFS, Barthel Index)
- Ability to work
- Patient-reported experience measures (PREMs)
- Additional IV antibiotic therapy exceeding 5 days for any reason
- Occurrence of severe adverse events related to antibiotic treatment
研究者
Dorothee Hornik
Scientific
University Of Cologne
研究点 (13)
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