Evidence map›Paper›PMID 32051007›Full record

ArticleTrials2020

Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection.

Achim J Kaasch, Anna Rommerskirchen, Martin Hellmich, Gerd Fätkenheuer, Reinhild Prinz-Langenohl, Siegbert Rieg, Winfried V Kern, Harald Seifert, SABATO trial group

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01792804 (Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.2field-weighted citation impact, top 36% 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.

NCT01792804 phase3completednot on this map

Early Oral Switch Therapy in Low-risk Staphylococcus Aureus Bloodstream Infection

TypeinterventionalSponsorHeinrich-Heine University, DuesseldorfRan2013 to 2020Enrolled215ConditionsStaphylococcus Aureus InfectionArmsTrimethoprim-Sulfamethoxazole, Clindamycin, Linezolid, Flucloxacillin, Cloxacillin
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. Article
  2. The Staphylococcus aureus Network Adaptive Platform Trial Protocol: New Tools for an Old Foe.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2022
    Article
  3. 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

9 authors at 3 institutions in 1 country.

Achim J KaaschInstitute of Medical Microbiology and Hospital Hygiene, Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany. achim.kaasch@hhu.de.ORCID http://orcid.org/0000-0002-6659-6738
Anna RommerskirchenInstitute of Medical Microbiology and Hospital Hygiene, Faculty of Medicine, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.
Martin HellmichInstitute of Medical Statistics and Computational Biology, Faculty of Medicine, University of Cologne, Cologne, Germany.
Gerd FätkenheuerDivision of Infectious Diseases, Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany.
Reinhild Prinz-LangenohlClinical Trial Center Cologne, University of Cologne, 50935, Cologne, Germany.
Siegbert RiegDivision of Infectious Diseases, Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, 79106, Freiburg, Germany.
Winfried V KernDivision of Infectious Diseases, Department of Medicine II, Medical Center, University of Freiburg, Faculty of Medicine, University of Freiburg, 79106, Freiburg, Germany.
Harald SeifertGerman Centre for Infection Research (DZIF), partner site Bonn-Cologne, Cologne, Germany.
SABATO trial group
University of Cologne · DEUniversity of Freiburg · DEHeinrich Heine University Düsseldorf · DE

Funding

Deutsche Forschungsgemeinschaft KA 3104/2
6 · The paper itself

Abstract

backgroundSABATO (Staphylococcus aureus bacteremia antibiotic treatment options) is a randomized, parallel-group, clinical non-inferiority trial designed to examine the efficacy and safety of early oral switch therapy in low-risk Staphylococcus aureus infection. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-015-0973-x ). Here we describe final amendments to the study protocol and discuss the underlying rationale. METHODS/

designThree major changes were introduced into the study protocol: (1) the inclusion and exclusion criteria were refined so that patients with certain comorbidities (end-stage renal disease, severe liver disease) and uninfected foreign bodies (orthopedic prosthesis, pacemaker, implanted cardiac cardioverter-defibrillator) became eligible for enrollment under certain conditions; (2) the target sample size was decreased by choosing a conventional non-inferiority margin of 10% and converting the interim analysis (215 patients) into the final analysis; and (3) an additional follow-up visit after 30 days was introduced to allow for a closer follow-up of patients.

conclusionChanges to the study protocol were introduced to improve the enrollment and follow-up of patients. Furthermore, the decrease of the sample size will facilitate completion of the trial.

trial registrationClinicalTrials.gov, NCT01792804. Registered on 13 February 2013. German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77.

Indexed as

Administration, IntravenousAdministration, OralAnti-Bacterial AgentsBacteremiaBlood CultureEquivalence Trials as TopicFollow-Up StudiesHumansLength of StayPatient Reported Outcome MeasuresRandomized Controlled Trials as TopicSecondary PreventionStaphylococcal InfectionsStaphylococcus aureusTreatment OutcomeAnti-Bacterial AgentsAntimicrobialBacteremiaBloodstream infectionIntravenousOral switch therapyPragmatic trialRandomized controlled trialStaphylococcus aureus

Identifiers

PMID32051007
PMCPMC7017556
OpenAlexW3005711389

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

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.