Protocol update for the SABATO trial: a randomized controlled trial to assess early oral switch therapy in low-risk Staphylococcus aureus bloodstream infection.
Administration, Intravenous
Administration, Oral
Anti-Bacterial Agents
/ administration & dosage
Bacteremia
/ drug therapy
Blood Culture
Follow-Up Studies
Humans
Length of Stay
Patient Reported Outcome Measures
Randomized Controlled Trials as Topic
Secondary Prevention
/ methods
Staphylococcal Infections
/ drug therapy
Staphylococcus aureus
/ isolation & purification
Treatment Outcome
Antimicrobial
Bacteremia
Bloodstream infection
Intravenous
Oral switch therapy
Pragmatic trial
Randomized controlled trial
Staphylococcus aureus
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Feb 2020
12 Feb 2020
Historique:
received:
31
10
2019
accepted:
21
01
2020
entrez:
14
2
2020
pubmed:
14
2
2020
medline:
15
12
2020
Statut:
epublish
Résumé
SABATO (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. Three 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. Changes 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. ClinicalTrials.gov, NCT01792804. Registered on 13 February 2013. German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77.
Sections du résumé
BACKGROUND
BACKGROUND
SABATO (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/DESIGN
METHODS
Three 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.
CONCLUSION
CONCLUSIONS
Changes 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 REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT01792804. Registered on 13 February 2013. German Clinical trials register, DRKS00004741. Registered on 4 October 2013, EudraCT 2013-000577-77.
Identifiants
pubmed: 32051007
doi: 10.1186/s13063-020-4102-0
pii: 10.1186/s13063-020-4102-0
pmc: PMC7017556
doi:
Substances chimiques
Anti-Bacterial Agents
0
Banques de données
ClinicalTrials.gov
['NCT01792804']
Types de publication
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
175Subventions
Organisme : Deutsche Forschungsgemeinschaft
ID : KA 3104/2
Références
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pubmed: 28974524
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pubmed: 31398375
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pubmed: 23664855
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pubmed: 26452342
J Infect. 2018 Dec;77(6):516-525
pubmed: 30179645