Partial Oral Antibiotic Treatment for Bacterial Brain Abscess (ORAL)
Brain Abscess, Cerebral Abscess
About this trial
This is an interventional treatment trial for Brain Abscess focused on measuring Oral antibiotics
Eligibility Criteria
Inclusion Criteria:
- A clinical presentation (e.g. headache, neurological deficit or fever) and cranial imaging (CT or MRI) consistent with brain abscess AND
- The physician responsible for the patient decides to treat the patient for bacterial brain abscess AND
- Ability to take and absorb oral medications (including by nasogastric tube) AND
- To have received relevant antibiotic therapy for bacterial brain abscess for 14 consecutive days before randomisation AND
- Expected to be treated with antibiotic therapy for at least another 14 days after time of randomisation AND
- No progression in symptom intensity or occurrence of new-onset neurological symptoms (excluding seizures) within five days before time of randomisation.
Exclusion Criteria (patients fulfilling either criteria):
- Expected substantially reduced compliance with treatment (e.g. IV drug abuse)
- Pregnancy (proven by positive urine or plasma human chorionic gonadotropin test in fertile women <50 years of age)
- Concomitant (empirical) brain abscess treatment for tuberculosis, nocardiosis, 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 or longer, uncontrolled HIV/AIDS, haematological malignancies, and organ transplant recipients
- Concomitant or unrelated infections necessitating IV antibiotics beyond seven days of duration after time of randomisation
- Previous enrolment into this trial
Sites / Locations
- Aalborg University HospitalRecruiting
- Aarhus University HospitalRecruiting
- RigshospitaletRecruiting
- Odense University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Oral antibiotics
Standard treatment
Patients will be randomised to oral antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess
Patients will be randomised to continuation of standard intravenous antibiotics after two weeks of appropriate antibiotic therapy for bacterial brain abscess since definitive aspiration/excision of brain abscess or, in case of no planned diagnostic neurosurgical procedure, since initiation of guideline recommended antibiotics for bacterial brain abscess