NCT06250023招募中不适用
Early Shift to Oral Antibiotic Treatment for Pyogenic Vertebral Osteomyelitis (SAVE) - a Open Label Non-inferiority Nation-wide Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
Background The current Danish National Guideline for treatment of pyogenic vertebral osteomyelitis (PVO) recommends 6 weeks antibiotic (AB) treatment, with a 2-week intravenous (IV) AB lead-in followed by 4 weeks oral AB for uncomplicated PVO, and 12 weeks AB treatment with a 2-4-week IV AB lead-in followed by 8 weeks oral AB for complicated PVO.
The primary objective of the current study is to investigate whether shortening the duration of IV AB to one week for both complicated and uncomplicated PVO is non-inferior to the current Danish National Guideline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosed with PVO by a physician based on clinical symptoms and findings consistent with PVO in combination with diagnostic imaging (MRI, PET/CT or PET/MRI)
- •The physician responsible for the patient decides to treat the patient for PVO
- •At time of randomization CRP has decreased to < 75% of peak value or to < 20 mg/l
- •At the time of randomization patient has received maximum 7 days of appropriate IV AB for PVO -
排除标准
- •Previous episodes of PVO within the past 24 months
- •Spinal implants inserted prior to current episode of PVO
- •Hypersensitivity to an AB intended for use in the patient and no alternative drugs available.
- •Oral ABs not possible due to suspicion of reduced absorption
- •Oral Abs not possible due to verified or expected bacterial susceptibility or due to expected toxicity of available regimen
- •Identification of fungus, mold, TB, Brucella, Actinomyces, Nocardia and P. aeruginosa as etiology
- •Severe immunocompromise defined as primary immunodeficiencies, uncontrolled HIV/AIDS, organ transplant recipients, hematological malignancies, patients undergoing biological therapy or chemotherapy and patients treated with prednisolone >=20 mg daily >14 days
- •Verified or expected reduced compliance (for example iv drug use)
- •Breastfeeding
- •Women of childbearing potential, who at the time of inclusion are not using and/or who will not use an effective anticonception method during the treatment period.
- •Patients not capable of providing informed consent at time of screening for inclusion
- •Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization -
结局指标
主要结局
Primary outcome
时间窗: Six months after completion of oral antibiotic treatment
Renewed course of intravenous antibiotic given for more than 7 days for treatment of pyogenic vertebral osteomyelitis
次要结局
- Secondary outcome 2(Six months after completion of oral antibiotic treatment)
- Secondary outcome 1(Six months after completion of oral antibiotic treatment)
- Secondary outcome 13(Six months after completion of oral antibiotic treatment)
- Secondary outcome 3(Six months after completion of oral antibiotic treatment)
- Secondary outcome 4(Six months after completion of oral antibiotic treatment)
- Secondary outcome 5(Six months after completion of oral antibiotic treatment)
- Secondary outcome 6(Six months after completion of oral antibiotic treatment)
- Secondary outcome 7(Six months after completion of oral antibiotic treatment)
- Secondary outcome 8(Six months after completion of oral antibiotic treatment)
- Secondary outcome 9(Six months after completion of oral antibiotic treatment)
- Secondary outcome 10(Six months after completion of oral antibiotic treatment)
- Secondary outcome 11(Six months after completion of oral antibiotic treatment)
- Secondary outcome 12(Six months after completion of oral antibiotic treatment)
研究者
Anne-Mette Lebech
Consultant, associate professor, MD Dsc
Rigshospitalet, Denmark
研究点 (1)
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