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

Aalborg University Hospital0 个研究点目标入组 400 人开始时间: 2019年9月27日最近更新: 2024年3月4日

试验速览

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•Adults =18 years of age with bacterial brain abscess defined as:
•1.A clinical presentation (e.g. headache, neurological deficit or fever) and cranial imaging (CT or MRI) consistent with brain abscess according to the hospital radiologist AND
•2.The physician responsible for the patient decides to treat the patient for bacterial brain abscess
•Further requirements for inclusion are:
•3.Ability to absorb oral medications (including by nasogastric tube)
•4.To have received guideline recommended empiric or targeted (according to in-vitro susceptibility) IV antibiotic therapy for bacterial brain abscess for 14 consecutive days or longer before randomisation and no additional aspiration or excision of brain abscess planned
•5.Expected to be treated with antibiotic therapy for at least another 14 days after time of randomisation
•6.No progression in neurological deficits or occurrence of new-onset neurological symptoms (excluding seizures) within five days before time of randomisation
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 100

•Patients fulfilling any of the following criteria will be excluded:
•1.Expected substantially reduced compliance with treatment (e.g. IV drug abuse)
•2.Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in premenopausal women)
•3.Concomitant treatment for proven or suspected CNS infection caused by mycobacteria, Nocardia spp., Pseudomonas spp., fungi, toxoplasmosis or other CNS parasites
•4.Device related brain abscesses (e.g. deep brain stimulators, ventriculo-peritoneal shunts)
•5.Severe immuno-compromise defined as ongoing need for biological- or chemotherapy, prednisolone >20 mg/day for =14 days, uncontrolled HIV/AIDS (see glossary), haematological malignancies, and organ transplant recipients
•6.Concomitant or unrelated infections necessitating IV antibiotics beyond seven days of duration after time of randomisation
•7.Previous enrolment into this trial

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