Early shift to oral antibiotic treatment of pyogenic vertebral osteomyelitis – a open label non-inferiority randomized nationwide study.

Rigshospitalet0 个研究点目标入组 530 人开始时间: 2023年11月1日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•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

•Previous episodes of PVO within the past 24 months, Verified or expected reduced compliance (for example iv drug use), Pregnancy, 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

发起方