Evidence map›Paper›PMID 28601833›Full record

Trial reportBMJ open2017

Targeted simplification versus antipseudomonal broad-spectrum beta-lactams in patients with bloodstream infections due to

Luis Eduardo López-Cortés, Clara Rosso-Fernández, María Núñez-Núñez, Lucía Lavín-Alconero, José Bravo-Ferrer, Ángel Barriga, Mercedes Delgado, Carmen Lupión, Pilar Retamar, Jesús Rodríguez-Baño and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
In one paragraph

Trial report in BMJ open, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02795949 (Randomized, Multicenter, Phase III, Controlled Clinical Trial, to Demonstrate the no Inferiority of Reduced Antibiotic Treatment vs a Broad Spectrum Betalactam Antipseudomonal Treatment in Patients With Bacteremia by Enterobacteriaceae), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

NCT02795949 phase3completednot on this map

Randomized, Multicenter, Phase III, Controlled Clinical Trial, to Demonstrate the no Inferiority of Reduced Antibiotic Treatment vs a Broad Spectrum Betalactam Antipseudomonal Treatment in Patients With Bacteremia by Enterobacteriaceae

TypeinterventionalSponsorFundación Pública Andaluza para la gestión de la Investigación en SevillaRan2016 to 2020Enrolled344ConditionsEnterobacteriaceae InfectionsArmsAntipseudomonal beta-lactam antibiotic, De-escalation(short-spectrum antibiotic)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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

11 authors.

Luis Eduardo López-CortésUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
Clara Rosso-FernándezUnidad de Investigación Clínica y Ensayos Clínicos (UICEC-HUVR), Hospitales Universitario Virgen del Rocío y Virgen Macarena, Sevilla, Spain.
María Núñez-NúñezUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
Lucía Lavín-AlconeroUnidad de Investigación Clínica y Ensayos Clínicos (UICEC-HUVR), Hospitales Universitario Virgen del Rocío y Virgen Macarena, Sevilla, Spain.
José Bravo-FerrerUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
Ángel BarrigaUnidad de Investigación Clínica y Ensayos Clínicos (UICEC-HUVR), Hospitales Universitario Virgen del Rocío y Virgen Macarena, Sevilla, Spain.
Mercedes DelgadoUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
Carmen LupiónUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
Pilar RetamarUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
Jesús Rodríguez-BañoUnidad Clínica de Enfermedades Infecciosas y Microbiología Clínica, Instituto de Biomedicina de Sevilla (IBiS)/Hospital Universitario Virgen Macarena /CSIC/Universidad de Sevilla, Sevilla, Spain.
SIMPLIFY Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionWithin the context of antimicrobial stewardship programmes, de-escalation of antimicrobial therapy is one of the proposed strategies for reducing the unnecessary use of broad-spectrum antibiotics (BSA). The empirical treatment of nosocomial and some healthcare-associated bloodstream infections (BSI) frequently includes a beta-lactam with antipseudomonal activity as monotherapy or in combination with other drugs, so there is a great opportunity to optimise the empirical therapy based on microbiological data. De-escalation is assumed as standard of care for experts in infectious diseases. However, it is less frequent than it would desirable. METHODS AND ANALYSIS: The SIMPLIFY trial is a multicentre, open-label, non-inferiority phase III randomised controlled clinical trial, designed as a pragmatic 'real-practice' trial. The aim of this trial is to demonstrate the non-inferiority of de-escalation from an empirical beta-lactam with antipseudomonal activity to a targeted narrow-spectrum antimicrobial in patients with BSI due to ETHICS AND DISSEMINATION: Each participating centre has obtained the approval of the ethics review committee, the agreement of the directors of the institutions and authorisation from the Spanish Regulatory Agency (Agencia Española del Medicamento y Productos Sanitarios). Data will be presented at international conferences and published in peer-reviewed journals. DISCUSSION: Strategies to reduce the use of BSA should be a priority. Most of the studies that support de-escalation are observational, retrospective and heterogeneous. A recent Cochrane review stated that well-designed clinical trials should be conducted to assess the safety and efficacy of de-escalation. TRIAL REGISTRATION NUMBER: The European Union Clinical Trials Register: EudraCT number 2015-004219-19. Clinical trials.gov: NCT02795949. Protocol version: V.2.0, dated 16 May 2016. All items from the WHO Trial Registration Data Set are included in the registry.

Indexed as

EnterobacteriaceaeAnti-Bacterial AgentsBacteremiabeta-LactamsDrug Administration RoutesEnterobacteriaceae InfectionsHumansMicrobial Sensitivity TestsPseudomonasPseudomonas InfectionsResearch DesignTreatment OutcomeAnti-Bacterial Agentsbeta-Lactamsantimicrobial stewardshipbloodstream infectionbroad-spectrum antibioticsDe-escalationEnterobacteriaceae

Identifiers

PMID28601833
PMCPMC5734512

What OpenQuestion holds

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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.