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

Aalborg University0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年9月9日

试验速览

暂无简介。

•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

•1. Hypersensitivity to an antibiotic intended for use in the patient and no
•alternative drugs available.
•2. Expected substantially reduced compliance with treatment
•3. Pregnancy/ lactating women.
•4. Concomitant treatment for proven or suspected CNS infection caused by
•mycobacteria, Nocardia spp., Pseudomonas spp., fungi, toxoplasmosis or other
•CNS parasites
•5. Device related brain abscesses (e.g. deep brain stimulators,
•ventriculo-peritoneal shunts)
•6. 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 (see Glossary), and organ transplant
•7. Concomitant or unrelated infections necessitating IV antibiotics beyond
•seven days of duration after time of randomisation
•8. Brain abscesses caused by Staphylococcus Aureus
•9. Previous enrolment into this trial

发起方

Aalborg University