Evidence map›Paper›PMID 34772441›Full record

Trial reportTrials2021

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

Jacob Bodilsen, Matthijs C Brouwer, Diederik van de Beek, Pierre Tattevin, Steven Tong, Pontus Naucler, Henrik Nielsen

Registry-linked trialOpen access · goldAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04140903 (Partial Oral Antibiotic Treatment for Bacterial Brain Abscess), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04140903 phase4recruitingnot on this map

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

TypeinterventionalSponsorHenrik NielsenRan2020 to 2028Enrolled400ConditionsBrain Abscess, Cerebral AbscessArmsEarly transition to oral antibiotics, Standard treatment of intravenous antibiotics
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Brain Abscesses in the Tropics.Current tropical medicine reports · 2023
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 6 countries.

Jacob BodilsenDepartment of Infectious Diseases, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark. Jacob.bodilsen@rn.dk.ORCID http://orcid.org/0000-0002-7398-814X
Matthijs C BrouwerEuropean Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.
Diederik van de BeekEuropean Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.
Pierre TattevinEuropean Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.
Steven TongVictorian Infectious Diseases Service, The Royal Melbourne Hospital, Parkville, Australia.
Pontus NauclerDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden.
Henrik NielsenEuropean Society for Clinical Microbiology and Infectious Diseases Study Group of Infections in the Brain (ESCMID), Basel, Switzerland.
Aalborg University Hospital · DKAmsterdam Neuroscience · NLKarolinska University Hospital · SEREseau NAtional de Rpe interDisciplinaire · FRThe Royal Melbourne Hospital · AU

Funding

Novo Nordisk Fonden (DK) 0057510
6 · The paper itself

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. 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 registrationClinicalTrials.gov NCT04140903, first registered 28.10.2019. EudraCT number: 2019-002845-39, first registered 03.07.2019.

Indexed as

Brain AbscessCOVID-19AdultAnti-Bacterial AgentsHumansQuality of LifeTreatment OutcomeAnti-Bacterial AgentsAntibioticsBrain abscessCerebral abscessIntravenousNon-inferiorityOralRandomized controlled trialTreatment

Identifiers

PMID34772441
PMCPMC8588941
OpenAlexW3214257359

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.