Oral antibiotics for treating bacterial brain abscess

Partial Oral Antibiotic Treatment for Bacterial Brain Abscess: an Open-label Randomised Non-inferiority Trial

This study tests if switching patients with bacterial brain abscess from IV antibiotics to oral antibiotics after two weeks is just as effective for their recovery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Aalborg University Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 4 sites (Aalborg and 3 other locations)
• Trial ID: NCT04140903 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of transitioning patients with bacterial brain abscess from intravenous (IV) antibiotics to oral antibiotics after two weeks of standard treatment. The study aims to determine if this approach is non-inferior to continuing IV antibiotics in terms of patient outcomes at six months. Participants will be randomly assigned to either continue with IV antibiotics or switch to oral antibiotics after the initial treatment period. The goal is to reduce hospital stays and associated complications while maintaining effective treatment.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with a bacterial brain abscess who have been stable and treated with IV antibiotics for at least 14 days.

Not a fit: Patients with expected poor compliance to treatment or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to safer and more cost-effective treatment options for patients with bacterial brain abscess.

How similar studies have performed: There have been no randomized controlled trials guiding the treatment of bacterial brain abscess, making this approach novel and untested.

Eligibility 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

Where this trial is running

Aalborg and 3 other locations

• Aalborg University Hospital — Aalborg, Denmark (RECRUITING)
• Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
• Rigshospitalet — Copenhagen, Denmark (RECRUITING)
• Odense University Hospital — Odense, Denmark (RECRUITING)

Study contacts

• Principal investigator: Jacob Bodilsen, MD — Aalborg University Hospital
• Study coordinator: Jacob Bodilsen, MD

Conditions: Brain Abscess, Cerebral Abscess, Oral antibiotics