Partial Oral Antibiotic Treatment for Bacterial Brain Abscess

• Status: Recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henrik Nielsen
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

1. A clinical presentation (e.g. headache, neurological deficit or fever) and cranial imaging (CT or MRI) consistent with brain abscess AND

2. The physician responsible for the patient decides to treat the patient for bacterial brain abscess AND

3. Ability to take and absorb oral medications (including by nasogastric tube) AND

4. To have received relevant antibiotic therapy for bacterial brain abscess for 14 consecutive days before randomisation AND

5. Expected to be treated with antibiotic therapy for at least another 14 days after time of randomisation AND

6. 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):

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 fertile women <50 years of age)

3. Concomitant (empirical) brain abscess treatment for tuberculosis, nocardiosis, 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 or longer, uncontrolled HIV/AIDS, 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