2023-507617-96-01招募中4 期
Early shift to oral antibiotic treatment of pyogenic vertebral osteomyelitis – a open label non-inferiority randomized nationwide study.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 530
- 试验地点
- 11
- 主要终点
- A composite of the following occurring from the time of shift to oral AB treatment to six months after completion of oral AB treatment: •All-cause mortality •Unplanned surgical intervention in relation to the spine •Relapse of bacteremia with the primary pathogen •Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture) •Renewed course of IV ABs given for >7 days for PVO
研究概览
简要总结
To investigate whether early transition to oral antibiotic (AB) treatment after one week of intravenous (IV) treatment is non-inferior to the current national guideline of continued IV AB treatment for two to four weeks followed by oral AB treatment for pyogenic vertebral osteomyelitis (PVO).
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
- •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
- •Verified or expected reduced compliance (for example iv drug use)
- •Diagnosed or suspected concomitant or unrelated infections necessitating IV AB therapy beyond 7 days of duration at the time of randomization
- •Breastfeeding
- •Patients not capable of providing informed consent at time of screening for inclusion
- •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
结局指标
主要结局
A composite of the following occurring from the time of shift to oral AB treatment to six months after completion of oral AB treatment: •All-cause mortality •Unplanned surgical intervention in relation to the spine •Relapse of bacteremia with the primary pathogen •Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture) •Renewed course of IV ABs given for >7 days for PVO
A composite of the following occurring from the time of shift to oral AB treatment to six months after completion of oral AB treatment: •All-cause mortality •Unplanned surgical intervention in relation to the spine •Relapse of bacteremia with the primary pathogen •Relapse of bacteria with the initial pathogen being cultured from relevant material from infected areas in relation to the spine or iliopsoas muscle (detected by culture) •Renewed course of IV ABs given for >7 days for PVO
次要结局
- Occurrence of each component of the composite primary endpoint from the time of shift to oral AB treatment to six months after completion of oral AB treatment.
- Median duration of hospital admission(s) from the time of shift to oral AB treatment to six months after completion of oral AB treatment (Admission defined as overnight stay at the department)
- Number of readmissions from the time of shift to oral AB treatment to six months after completion of oral AB treatment
- Proportion of patients receiving additional oral AB therapy beyond the duration defined in the protocol
- Proportion of patients having early termination of allocated treatment strategy due to adverse events, patient preference, or any other reason
- Proportion of patients experiencing complications associated with IV treatment (e.g., catheter infections, phlebitis, bleeding, venous thrombosis, need for replacement of catheter) from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
- Proportion of patients experiencing severe adverse events from ABs from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
- Proportion of patients experiencing adverse events from ABs from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
- Proportion of patients diagnosed with Clostridioides difficile associated diarrhea from the time of initiation of IV treatment for PVO to six months after completion of oral AB treatment
- Quality of life scores (EQ-5D) at the following timepoints: Randomization, 1 week after the end of AB therapy, 1 month after the end of AB therapy, 6 months after the end of oral AB therapy, and 12 months after the end of oral AB therapy
- Resource allocation/cost assessment determined by a combination of EQ5D, DALYs, Days of hospital admission and antibiotic prescribing costs
- CRP, WBC, alkaline phosphatase and procalcitonin at randomization as well as CRP, WBC, alkaline phosphatase weekly during treatment and at week 4, 12 and 24 after completion of oral AB treatment.
- Presence of microbial cell-free DNA in blood samples at the time of randomization and 6 months after the end of oral AB therapy
研究者
Anne-Mette
Scientific
Rigshospitalet
研究点 (11)
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