Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)

Abstract Background 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 equally effective. Methods This investigator-initiated, international,...

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Autores principales:	Jacob Bodilsen, Matthijs C. Brouwer, Diederik van de Beek, Pierre Tattevin, Steven Tong, Pontus Naucler, Henrik Nielsen
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Brain abscess Cerebral abscess Treatment Randomized controlled trial Non-inferiority Antibiotics Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/8a75058dc71f4a3bb91c9469ac521268
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spelling	oai:doaj.org-article:8a75058dc71f4a3bb91c9469ac5212682021-11-14T12:31:15ZPartial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)10.1186/s13063-021-05783-81745-6215https://doaj.org/article/8a75058dc71f4a3bb91c9469ac5212682021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05783-8https://doaj.org/toc/1745-6215Abstract Background 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 equally effective. Methods This 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. Discussion The 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 registration ClinicalTrials.gov NCT04140903, first registered 28.10.2019. EudraCT number: 2019-002845-39, first registered 03.07.2019Jacob BodilsenMatthijs C. BrouwerDiederik van de BeekPierre TattevinSteven TongPontus NauclerHenrik NielsenBMCarticleBrain abscessCerebral abscessTreatmentRandomized controlled trialNon-inferiorityAntibioticsMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-17 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Brain abscess Cerebral abscess Treatment Randomized controlled trial Non-inferiority Antibiotics Medicine (General) R5-920
spellingShingle	Brain abscess Cerebral abscess Treatment Randomized controlled trial Non-inferiority Antibiotics Medicine (General) R5-920 Jacob Bodilsen Matthijs C. Brouwer Diederik van de Beek Pierre Tattevin Steven Tong Pontus Naucler Henrik Nielsen Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
description	Abstract Background 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 equally effective. Methods This 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. Discussion The 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 registration ClinicalTrials.gov NCT04140903, first registered 28.10.2019. EudraCT number: 2019-002845-39, first registered 03.07.2019
format	article
author	Jacob Bodilsen Matthijs C. Brouwer Diederik van de Beek Pierre Tattevin Steven Tong Pontus Naucler Henrik Nielsen
author_facet	Jacob Bodilsen Matthijs C. Brouwer Diederik van de Beek Pierre Tattevin Steven Tong Pontus Naucler Henrik Nielsen
author_sort	Jacob Bodilsen
title	Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
title_short	Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
title_full	Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
title_fullStr	Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
title_full_unstemmed	Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)
title_sort	partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (oral)
publisher	BMC
publishDate	2021
url	https://doaj.org/article/8a75058dc71f4a3bb91c9469ac521268
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Partial oral antibiotic treatment for bacterial brain abscess: an open-label randomized non-inferiority trial (ORAL)

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