Abstract
BackgroundThe advised standard treatment for bacterial brain abscess following surgery is 6 to 8 weeks of intravenous (IV) antibiotic treatment, but an early switch to oral antibiotic treatment has been suggested to be equally effective.MethodsThis investigator-initiated, international, multi-center, parallel group, open-label, randomized (1:1 allocation) controlled trial will examine if oral treatment after 2 weeks of IV antibiotic therapy is non-inferior to standard 6–8 weeks of IV antibiotics for bacterial brain abscess in adults (≥ 18 years of age). The study will be conducted at hospitals across Denmark, the Netherlands, France, Australia, and Sweden. Exclusion criteria are severe immunocompromise or impaired gastro-intestinal absorption, pregnancy, device-related brain abscesses, and brain abscess caused by nocardia, tuberculosis, or Pseudomonas spp. The primary objective is a composite endpoint at 6 months after randomization consisting of all-cause mortality, intraventricular rupture of brain abscess, unplanned re-aspiration or excision of brain abscess, relapse, or recurrence. The primary endpoint will be adjudicated by an independent blinded endpoint committee. Secondary outcomes include extended Glasgow Outcome Scale scores and all-cause mortality at end of treatment as well as 3, 6, and 12 months since randomization, completion of assigned treatment, IV catheter associated complications, durations of admission and antibiotic treatment, severe adverse events, quality of life scores, and cognitive evaluations. The planned sample size is 450 patients for a one-sided alpha of 0.025 and a power of 90% to exclude a difference in favor of standard treatment of more than 10%. Date of initiation of first study center was November 3, 2020, with active recruitment for 3 years and follow-up for 1 year of all patients.DiscussionThe results of this study may guide future recommendations for treatment of bacterial brain abscess. If early transition to oral antibiotics proves non-inferior to standard IV treatment, this will provide considerable health and costs benefits.Trial registrationClinicalTrials.gov NCT04140903, first registered 28.10.2019. EudraCT number: 2019-002845-39, first registered 03.07.2019
Highlights
Background and rationale {6a} Brain abscess is a serious infection with a considerable impact on patients’ lives [1,2,3,4,5]
Sequelae occur frequently in surviving patients, and the total rate of unfavorable outcome defined as a Glasgow Outcome Scale (GOS) score < 5 was found to be 32% after 6 months since discharge based on unpublished data from the nationwide prospective clinical database of the Danish Study Group of Infections of the Brain (DASGIB) in years 2015 to 2018 [10, 11]
Early oral antibiotic therapy may lead to reduced compliance and may be inferior to standard IV treatment
Summary
Background and rationale {6a} Brain abscess is a serious infection with a considerable impact on patients’ lives [1,2,3,4,5] It is a rare disease, the incidence has been increasing in the past 30 years with rates of 0.9/100,000/year corresponding to 6700 cases per year in Europe [6, 7]. There are no randomized controlled trials on antibiotic treatment of brain abscess to evaluate the standard regimen in immunocompetent individuals of intravenous (IV) 3rd generation cephalosporin and metronidazole for 6–8 weeks [3, 12]. The DMSC will constitute its own plan of monitoring and meetings This charter will define the minimum of obligations and primary responsibilities of the DMSC as perceived by the Steering Committee, its relationship with other trial components, its membership, and the purpose and timing of its meetings. The advised standard treatment for bacterial brain abscess following surgery is 6 to 8 weeks of intravenous (IV) antibiotic treatment, but an early switch to oral antibiotic treatment has been suggested to be effective
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