Abstract
BackgroundMost serious complications of infective endocarditis (IE) appear in the so-called “critical phase” of the disease, which represents the first days after diagnosis. The majority of patients overcoming the acute phase has a favorable outcome, yet they remain hospitalized for a long period of time mainly to complete antibiotic therapy. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen.MethodsMulticenter, prospective, randomized, controlled open-label, phase IV clinical trial with a non-inferiority design to evaluate the efficacy of a short course (2 weeks) of parenteral antibiotic therapy compared with conventional antibiotic therapy (4–6 weeks).Sample: patients with IE caused by gram-positive cocci, having received at least 10 days of conventional antibiotic treatment, and at least 7 days after surgery when indicated, without clinical, analytical, microbiological or echocardiographic signs of persistent infection. Estimated sample size: 298 patients. Intervention: Control group: standard duration antibiotic therapy, (4 to 6 weeks) according to ESC guidelines recommendations. Experimental group: short-course antibiotic therapy for 2 weeks. The incidence of the primary composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion in the study will be prospectively registered and compared.ConclusionsSATIE will investigate whether a two weeks short-course of intravenous antibiotics in patients with IE caused by gram-positive cocci, without signs of persistent infection, is not inferior in safety and efficacy to conventional antibiotic treatment (4–6 weeks).Trial registrationClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020).EudraCT 2019–003358-10.
Highlights
Most serious complications of infective endocarditis (IE) appear in the so-called “critical phase” of the disease, which represents the first days after diagnosis
Nowadays patients diagnosed with IE are older, have much comorbidities, such as diabetes mellitus, chronic renal failure, chronic obstructive pulmonary disease, or cardiac implantable electronic devices, and a higher level of frailty compared to previous decades [3, 4]
Regarding microorganisms causing IE, the most frequently involved group is staphylococci, Staphylococcus aureus; its incidence has decreased over the last decade in favour of coagulase-negative staphylococci, and enterococci
Summary
Most serious complications of infective endocarditis (IE) appear in the so-called “critical phase” of the disease, which represents the first days after diagnosis. The major hypothesis of this trial is that in patients with clinically stable IE and adequate response to antibiotic treatment, without signs of persistent infection, periannular complications or metastatic foci, a shorter antibiotic time period would be as efficient and safe as the classic 4 to 6 weeks antibiotic regimen. Regarding microorganisms causing IE, the most frequently involved group is staphylococci, Staphylococcus aureus; its incidence has decreased over the last decade in favour of coagulase-negative staphylococci, and enterococci. This fact is most probably due to a progressively older population as well as a more frequent invasive manipulation of patients (such as the use of intravenous catheters, haemodialysis and other invasive techniques) [2, 5]
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