Oral antibiotics for treating bacterial brain abscess

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: jacob.bodilsen@rn.dk
• Phone: +45 97663920

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Cognitive Function and Fatigue After Brain Abscess

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.