Partial Oral Antibiotic Treatment for Bacterial Brain Abscess
Recruiting now · Phase 4
Conditions studied: Brain Abscess, Cerebral Abscess
In brief
The investigators aim to determine if oral antibiotics are clinically acceptable as treatment of brain abscess. Following 2 weeks of standard intravenous antibiotic therapy, half of patients will continue with this treatment for another 4 weeks or longer while the other half will be assigned to oral antibiotics for the remaining duration of treatment.
Key facts
- Study ID
- NCT04140903
- Run by
- Henrik Nielsen
- People needed
- 400
- Starts
- 2020-11-06
- Expected to finish
- 2028-08-31
- Last updated by the study team
- 2025-01-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Aalborg University Hospital — Aalborg, Denmark (enrolling)
- Aarhus University Hospital — Aarhus, Denmark (enrolling)
- Rigshospitalet — Copenhagen, Denmark (enrolling)
- Odense University Hospital — Odense, Denmark (enrolling)
Full record on ClinicalTrials.gov
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