Short-course Antibiotic Treatment in Gram-positive Cocci Infective Endocarditis — SATIE  

Endocarditis, Bacterial Clinical Trial

Official title: Short-course Antibiotic Regimen Compared to Conventional Antibiotic Treatment for Gram-positive Cocci Infective Endocarditis: Randomized Clinical Trial

Status Terminated

Clinical Trial Summary

Background: it is well known that most serious complications of infective endocarditis (IE) appear in the so-called "critical phase" of the disease, which are the first days after diagnosis. Subsequently, the vast majority of patients who overcome this acute phase has a favourable evolution, and usually stay in the hospital for a long time only to complete antibiotic therapy.

In stable patients with adequate response to antibiotic treatment, without signs of persistent infection or metastatic foci such as spondylodiscitis, it is likely that a shorter antibiotic regimen would be an efficient and safe alternative, as has already been confirmed in patients with IE on tricuspid valves caused by a microorganism considered virulent such as S. aureus. This attractive alternative would improve patients' quality of life, save costs, and decrease the risk of complications related to the adverse effects of prolonged antibiotic treatment.

Objectives: to compare the incidence of the composite endpoint of all-cause mortality, unplanned cardiac surgery, symptomatic embolisms and relapses within 6 months after the inclusion between patients with IE caused by gram-positive cocci receiving a short-course of 2 weeks of antibiotic therapy and those patients receiving conventional antibiotic therapy (4-6 weeks).

Methodology: multicenter, prospective, randomized, controlled open-label, phase IV clinical trial. 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 antibiotic therapy, according to ESC guidelines recommendations, for 4 to 6 weeks. Experimental group: short-course antibiotic therapy for 2 weeks. The prevalence of previously known risk factors for adverse events will be compared between the two groups to confirm that randomization have worked properly. The incidence of the 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial

• NCT number: NCT04222257
• Study type: Interventional
• Source: Hospital San Carlos, Madrid
• Status: Terminated
• Phase: Phase 4
• Start date: January 26, 2021
• Completion date: April 1, 2023