Partial Oral Antibiotic Treatment for Bacterial Brain Abscess — ORAL  

Brain Abscess Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Treatment of brain abscess remains a considerable challenge due to the precarious location of the infection and the impenetrability of the blood-brain-barrier for most drugs. Thus, cure usually requires a combination of neurosurgical evacuation of abscess material and 6-8 weeks of high-dose intravenous (IV) antibiotic therapy to ensure eradication of bacteria within the abscess cavity. Disadvantages include risks of nosocomial infections and line-associated complications (e.g. bleeding, venous thrombosis, or need for replacement due to malfunction) in addition to the considerable costs of such long-term admission. However, improved insights into the pharmacokinetic properties and favourable bioavailability of some oral antibiotics may allow such treatment at an early stage. To date, there are no randomised controlled trials to guide treatment of bacterial brain abscess.

The investigators wish to determine whether a treatment strategy of transition to oral antibiotics after two weeks of treatment is non-inferior to continued IV antibiotics in clinically stable brain abscess patients assessed by the proportion with a favourable outcome at six months since randomisation. ;

Related Conditions & MeSH terms

• Abscess
• Brain Abscess
• Cerebral Abscess

• NCT number: NCT04140903
• Study type: Interventional
• Source: Aalborg University Hospital
• Contact: Jacob Bodilsen, MD
• Phone: +45 97663920
• Email: jacob.bodilsen@rn.dk
• Status: Recruiting
• Phase: Phase 4
• Start date: November 6, 2020
• Completion date: August 31, 2025