Partial oral antibiotic treatment for bacterial brain abscess: An open-label randomised non-inferiority trial (ORAL)

Aalborg University Hospital0 个研究点目标入组 450 人开始时间: 2023年6月27日最近更新: 2024年7月22日

适应症

试验速览

暂无简介。

•Age >17 years, Clinical presentation and brain imaging consistent with brain abscess, The physician in charge decides to treat the patient for brain abscess, Able to absorb oral medications, To have received guideline recommended intravenous antimicrobials for at least 14 consecutive days or longer before randomisation and no additional aspiraiton or excision of brain abscess planned., Expected to be treated for at least another 14 days after randomisation., No progression in neurological deficits or new-onset neurological symptoms (excluding seizures) within 5 days before randomisation

•Hypersensitivity to the intended antimicrobial with no other alternative drugs available, Patients not capable of providing informed consent., Expected substantially reduced compliance with treatment, Pregnancy (confirmed by urine or plasma human chorionic gonadotropin test in fertile women), Lactating women, Concomitant treatment for proven or suspected CNS infection caused by mycobacteria, nocardia spp., pseudomonas spp., fungi, toxoplasmosis, or other CNS parasites, Device related brain abscesses (e.g. deep brain stimulators, ventriculo-peritoneal shunts), Severe immuno-compromise defined as ongoing need for biological- or chemotherapy, prednisolone >20 mg/day for >14 days, uncontrolled HIV/AIDS, haematological malignancies, and organ transplant recipients, Concomitant or unrelated infections requiring >7 days of intravenous antimicrobials, Previous enrolment into this trial

发起方