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Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).

ABSTRACT: BACKGROUND: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 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. METHODS:Multicenter, 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. CONCLUSIONS:SATIE 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 REGISTRATION:ClinicalTrials.gov Identifier: NCT04222257 (January 7, 2020). EudraCT 2019-003358-10.

SUBMITTER: Olmos C

PROVIDER: S-EPMC7298739 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).

Olmos Carmen C Vilacosta Isidre I López Javier J Sáez Carmen C Anguita Manuel M García-Granja Pablo Elpidio PE Sarriá Cristina C Silva Jacobo J Álvarez-Álvarez Belén B Martínez-Monzonis María Amparo MA Castillo Juan Carlos JC Seijas José J López-Picado Amanda A Peral Vicente V Maroto Luis L San Román J Alberto JA

BMC infectious diseases 20200616 1

<h4>Background</h4>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 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 p ...[more]

PMID: 32546269

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Project description:What is known and objectiveGram-negative bacteremia remains a major health problem around the world. The optimal duration of antibiotic treatment has been poorly defined, and there are significant differences of opinion between clinicians. We conducted this systematic review and meta-analysis to compare the clinical outcomes of short-course and long-course treatments in patients with uncomplicated gram-negative bacteremia.MethodsWe searched public databases (PubMed, EMBASE and Cochrane Library) to identify eligible studies. The primary outcomes were all-cause mortality and the incidence of recurrent bacteremia through day 30. We used the Cochrane risk of bias assessment tool to evaluate the risk of bias for randomized controlled trials (RCTs) and the Newcastle-Ottawa Scale for non-RCTs.Results and discussionSix studies involving 2689 patients were included in the systematic review and meta-analysis. No significant difference was found between short-course and long-course antibiotic treatments in 30-day mortality (risk ratio [RR] 0.85; 95% confidence interval [CI] 0.65-1.13; P = .26), 30-day recurrent bacteremia (RR 1.07; 95% CI 0.68-1.67; P = .78), 90-day mortality (RR 0.84; 95% CI 0.57-1.24; P = .38), 90-day recurrent bacteremia (RR 0.98; 95% CI 0.50-1.89; P = .94), adverse events (RR 1.14; 95% CI 0.89-1.45; P = .30), Clostridium difficile infection (RR 0.86; 95% CI 0.40-1.86; P = .71) or resistance development (RR 1.19; 95% CI 0.66-2.14; P = .57).What is new and conclusionShort-course was non-inferior to long-course antibiotic treatments for patients with uncomplicated gram-negative bacteremia. Considering the drug-related side effects and cost-effectiveness, a shorter duration of antibiotic treatment may be preferable for this particular population. However, additional high-quality RCTs are needed to further assess whether a shorter course of antibiotic treatment is of greater benefit for patients with uncomplicated gram-negative bacteremia.

Dataset Information

Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).

Publications

Short-course antibiotic regimen compared to conventional antibiotic treatment for gram-positive cocci infective endocarditis: randomized clinical trial (SATIE).

Similar Datasets

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