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

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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.

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Most cited references 8

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Duration of antibiotic therapy for bacteremia: a systematic review and meta-analysis

Thomas C Havey, Robert Fowler, Nick Daneman (2011)

Introduction The optimal duration of antibiotic therapy for bloodstream infections is unknown. Shorter durations of therapy have been demonstrated to be as effective as longer durations for many common infections; similar findings in bacteremia could enable hospitals to reduce antibiotic utilization, adverse events, resistance and costs. Methods A search of the MEDLINE, EMBASE and COCHRANE databases was conducted for the years 1947-2010. Controlled trials were identified that randomized patients to shorter versus longer durations of treatment for bacteremia, or the infectious foci most commonly causing bacteremia in critically ill patients (catheter-related bloodstream infections (CRBSI), intra-abdominal infections, pneumonia, pyelonephritis and skin and soft-tissue infections (SSTI)). Results Twenty-four eligible trials were identified, including one trial focusing exclusively on bacteremia, zero in catheter related bloodstream infection, three in intra-abdominal infection, six in pyelonephritis, thirteen in pneumonia and one in skin and soft tissue infection. Thirteen studies reported on 227 patients with bacteremia allocated to 'shorter' or 'longer' durations of treatment. Outcome data were available for 155 bacteremic patients: neonatal bacteremia (n = 66); intra-abdominal infection (40); pyelonephritis (9); and pneumonia (40). Among bacteremic patients receiving shorter (5-7 days) versus longer (7-21 days) antibiotic therapy, no significant difference was detected with respect to rates of clinical cure (45/52 versus 47/49, risk ratio 0.88, 95% confidence interval [CI] 0.77-1.01), microbiologic cure (28/28 versus 30/32, risk ratio 1.05, 95% CI 0.91-1.21), and survival (15/17 versus 26/29, risk ratio 0.97, 95% CI 0.76-1.23). Conclusions No significant differences in clinical cure, microbiologic cure and survival were detected among bacteremic patients receiving shorter versus longer duration antibiotic therapy. An adequately powered randomized trial of bacteremic patients is needed to confirm these findings.

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Enterococcal endocarditis in the beginning of the 21st century: analysis from the International Collaboration on Endocarditis-Prospective Cohort Study.

C. Chirouze, E Athan, F. Alla … (2013)

Enterococci are reportedly the third most common group of endocarditis-causing pathogens but data on enterococcal infective endocarditis (IE) are limited. The aim of this study was to analyse the characteristics and prognostic factors of enterococcal IE within the International Collaboration on Endocarditis. In this multicentre, prospective observational cohort study of 4974 adults with definite IE recorded from June 2000 to September 2006, 500 patients had enterococcal IE. Their characteristics were described and compared with those of oral and group D streptococcal IE. Prognostic factors for enterococcal IE were analysed using multivariable Cox regression models. The patients' mean age was 65 years and 361/500 were male. Twenty-three per cent (117/500) of cases were healthcare related. Enterococcal IE were more frequent than oral and group D streptococcal IE in North America. The 1-year mortality rate was 28.9% (144/500). E. faecalis accounted for 90% (453/500) of enterococcal IE. Resistance to vancomycin was observed in 12 strains, eight of which were observed in North America, where they accounted for 10% (8/79) of enterococcal strains, and was more frequent in E. faecium than in E. faecalis (3/16 vs. 7/364 , p 0.01). Variables significantly associated with 1-year mortality were heart failure (HR 2.4, 95% CI 1.7--3.5, p <0.0001), stroke (HR 1.9, 95% CI 1.3--2.8, p 0.001) and age (HR 1.02 per 1-year increment, 95% CI 1.01--1.04, p 0.002). Surgery was not associated with better outcome. Enterococci are an important cause of IE, with a high mortality rate. Healthcare association and vancomycin resistance are common in particular in North America.

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Early-Onset Ventilator-Associated Pneumonia in Adults Randomized Clinical Trial: Comparison of 8 versus 15 Days of Antibiotic Treatment

Gilles Capellier, Hélène Mockly, Claire Charpentier … (2012)

Purpose The optimal treatment duration for ventilator-associated pneumonia is based on one study dealing with late-onset of the condition. Shortening the length of antibiotic treatment remains a major prevention factor for the emergence of multiresistant bacteria. Objective To demonstrate that 2 different antibiotic treatment durations (8 versus 15 days) are equivalent in terms of clinical cure for early-onset ventilator-associated pneumonia. Methods Randomized, prospective, open, multicenter trial carried out from 1998 to 2002. Measurements The primary endpoint was the clinical cure rate at day 21. The mortality rate was evaluated on days 21 and 90. Results 225 patients were included in 13 centers. 191 (84.9%) patients were cured: 92 out of 109 (84.4%) in the 15 day cohort and 99 out of 116 (85.3%) in the 8 day cohort (difference = 0.9%, odds ratio = 0.929). 95% two-sided confidence intervals for difference and odds ratio were [−8.4% to 10.3%] and [0.448 to 1.928] respectively. Taking into account the limits of equivalence (10% for difference and 2.25 for odds ratio), the objective of demonstrative equivalence between the 2 treatment durations was fulfilled. Although the rate of secondary infection was greater in the 8 day than the 15 day cohort, the number of days of antibiotic treatment remained lower in the 8 day cohort. There was no difference in mortality rate between the 2 groups on days 21 and 90. Conclusion Our results suggest that an 8-day course of antibiotic therapy is safe for early-onset ventilator-associated pneumonia in intubated patients. Trial Registration ClinicalTrials.gov NCT01559753

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Author and article information

Contributors

Carmen Olmos:

ORCID: http://orcid.org/0000-0001-9544-0508

carmen.olmosblanco@gmail.com

Journal

Journal ID (nlm-ta): BMC Infect Dis

Journal ID (iso-abbrev): BMC Infect. Dis

Title: BMC Infectious Diseases

Publisher: BioMed Central (London )

ISSN (Electronic): 1471-2334

Publication date (Electronic): 16 June 2020

Publication date PMC-release: 16 June 2020

Publication date Collection: 2020

Volume: 20

Electronic Location Identifier: 417

Affiliations

[1 ]GRID grid.411068.a, ISNI 0000 0001 0671 5785, Instituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), ; Prof. Martín Lagos s/n, 28040 Madrid, Spain

[2 ]GRID grid.411057.6, ISNI 0000 0000 9274 367X, Servicio de Cardiología, , Instituto de Ciencias del Corazón (ICICOR), CIBERCV, ; Valladolid, Spain

[3 ]GRID grid.411251.2, ISNI 0000 0004 1767 647X, Servicio de Medicina Interna-Infecciosas, , Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, ; Madrid, Spain

[4 ]GRID grid.411349.a, ISNI 0000 0004 1771 4667, Servicio de Cardiología, , Hospital Universitario Reina Sofía de Córdoba, ; Córdoba, Spain

[5 ]Servicio de Cirugía Cardiaca, Hospital Universitario Central de Oviedo, Oviedo, Spain

[6 ]GRID grid.411048.8, ISNI 0000 0000 8816 6945, Servicio de Cardiología y Unidad Coronaria, , Complejo Hospitalario Universitario de Santiago de Compostela, ; Santiago de Compostela, Spain

[7 ]GRID grid.414780.e, Unidad de Investigación y Ensayos Clinicos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), ; Madrid, Spain

[8 ]GRID grid.411164.7, ISNI 0000 0004 1796 5984, Servicio de Cardiología, , Hospital Universitario de Son Espases, ; Palma de Mallorca, Spain

Author information

Carmen Olmos http://orcid.org/0000-0001-9544-0508

Article

Publisher ID: 5132

DOI: 10.1186/s12879-020-05132-1

PMC ID: 7298739

PubMed ID: 32546269

SO-VID: eb5441d0-fd96-40ab-afdd-ed82b10f43fa

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 27 April 2020

Date accepted : 1 June 2020

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100004587, Instituto de Salud Carlos III;

Award ID: Fondos FEDER, PI19/00518

Award Recipient : Carmen Olmos

Custom metadata

ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: infective endocarditis,short-course,antibiotic therapy

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ScienceOpen disciplines: Infectious disease & Microbiology

Keywords: infective endocarditis, short-course, antibiotic therapy

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

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Abstract

Background

Methods

Conclusions

Trial registration

Related collections

Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 8

Duration of antibiotic therapy for bacteremia: a systematic review and meta-analysis

Enterococcal endocarditis in the beginning of the 21st century: analysis from the International Collaboration on Endocarditis-Prospective Cohort Study.

Early-Onset Ventilator-Associated Pneumonia in Adults Randomized Clinical Trial: Comparison of 8 versus 15 Days of Antibiotic Treatment

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