Evidence map›Paper›PMID 32546269›Full record

Trial reportBMC infectious diseases2020

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

Carmen Olmos, Isidre Vilacosta, Javier López, Carmen Sáez, Manuel Anguita, Pablo Elpidio García-Granja, Cristina Sarriá, Jacobo Silva, Belén Álvarez-Álvarez, María Amparo Martínez-Monzonis and 6 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVEquivalence TrialMulticenter Study
In one paragraph

Trial report in BMC infectious diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04222257 (Short-course Antibiotic Regimen Compared to Conventional Antibiotic Treatment for Gram-positive Cocci Infective Endocarditis), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04222257 phase4terminatednot on this mapstarted 2021, after this paper: background citation

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

TypeinterventionalSponsorCarmen Olmos BlancoRan2021 to 2023Enrolled20ConditionsEndocarditis, BacterialArmsAntibiotics
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. Synthesis and Evaluation of Some New 4Pharmaceuticals (Basel, Switzerland) · 2022
    Article
  4. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 7 institutions in 1 country.

Carmen OlmosInstituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain. carmen.olmosblanco@gmail.com.ORCID http://orcid.org/0000-0001-9544-0508
Isidre VilacostaInstituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain.
Javier LópezServicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.
Carmen SáezServicio de Medicina Interna-Infecciosas, Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain.
Manuel AnguitaServicio de Cardiología, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain.
Pablo Elpidio García-GranjaServicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.
Cristina SarriáServicio de Medicina Interna-Infecciosas, Instituto de Investigación Sanitaria del Hospital Universitario de la Princesa, Madrid, Spain.
Jacobo SilvaServicio de Cirugía Cardiaca, Hospital Universitario Central de Oviedo, Oviedo, Spain.
Belén Álvarez-ÁlvarezServicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
María Amparo Martínez-MonzonisServicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
Juan Carlos CastilloServicio de Cardiología, Hospital Universitario Reina Sofía de Córdoba, Córdoba, Spain.
José SeijasServicio de Cardiología y Unidad Coronaria, Complejo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain.
Amanda López-PicadoUnidad de Investigación y Ensayos Clinicos. Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Madrid, Spain.
Vicente PeralServicio de Cardiología, Hospital Universitario de Son Espases, Palma de Mallorca, Spain.
Luis MarotoInstituto Cardiovascular, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdSSC), Prof. Martín Lagos s/n, 28040, Madrid, Spain.
J Alberto San RománServicio de Cardiología, Instituto de Ciencias del Corazón (ICICOR), CIBERCV, Valladolid, Spain.
Instituto de Investigación Sanitaria del Hospital Clínico San Carlos · ESCentro de Investigación en Red en Enfermedades Cardiovasculares · ESComplejo Hospitalario Universitario de Santiago · ESHospital Universitario de La Princesa · ESHospital Universitario Reina Sofía · ESHospital Universitario Central de Asturias · ESHospital Universitario Son Espases · ES

Funding

Instituto de Salud Carlos III Fondos FEDER, PI19/00518
6 · The paper itself

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.

interventionControl 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.

Indexed as

Administration, IntravenousAdolescentAdultAgedAged, 80 and overAnti-Bacterial AgentsClinical ProtocolsEndocarditis, BacterialFemaleFollow-Up StudiesGram-Positive Bacterial InfectionsGram-Positive CocciHumansMaleMiddle AgedProspective StudiesAnti-Bacterial AgentsAntibiotic therapyInfective endocarditisShort-course

Identifiers

PMID32546269
PMCPMC7298739
OpenAlexW3034939352

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.