Evidence map›Paper›PMID 25091790›Full record

Trial reportIntensive care medicine2014

De-escalation versus continuation of empirical antimicrobial treatment in severe sepsis: a multicenter non-blinded randomized noninferiority trial.

Marc Leone, Carole Bechis, Karine Baumstarck, Jean-Yves Lefrant, Jacques Albanèse, Samir Jaber, Alain Lepape, Jean-Michel Constantin, Laurent Papazian, Nicolas Bruder and 6 more

Erratum issued 2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Intensive care medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 119 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
119citing papers in PubMed, 7 pooled it
–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.

NCT01626612 phase3completednot on this map

De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)

TypeinterventionalSponsorAssistance Publique Hopitaux De MarseilleRan2012 to 2013Enrolled120ConditionsSevere SepsisArmscontinuation of the empirical antimicrobial therapy, streamlining of the empirical antimicrobial therapy
NCT02920463 completednot on this mapstarted 2016, after this paper: background citation

DetermInants of Antimicrobial Use aNd De-escalAtion in Critical Care (DIANA Study)

TypeobservationalSponsorUniversity Hospital, GhentRan2016 to 2018Enrolled1,495ConditionsInfection
3 · Its place in the literature

Who cites it

119 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. [S3 guideline on sepsis-prevention, diagnosis, therapy, and follow-up care-update 2025].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2025
    Guideline
  2. Pooled it
  3. [S3 Guideline Sepsis-prevention, diagnosis, therapy, and aftercare : Long version].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2020
    Guideline
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  8. Trial
  9. Trial
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  11. Review
  12. Article
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  15. Optimal antibiotic use in the intensive care unit.Critical care (London, England) · 2025
    Review
  16. Review
  17. Review
  18. Article
  19. Review
  20. Article

59 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Marc LeoneService d'anesthésie et de réanimation, Hôpital Nord, Chemin des Bourrely, 13015, Marseille, France, marc.leone@ap-hm.fr.
Carole Bechis
Karine Baumstarck
Jean-Yves Lefrant
Jacques Albanèse
Samir Jaber
Alain Lepape
Jean-Michel Constantin
Laurent Papazian
Nicolas Bruder
Bernard Allaouchiche
Karine Bézulier
François Antonini
Julien Textoris
Claude Martin
AZUREA Network Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn patients with severe sepsis, no randomized clinical trial has tested the concept of de-escalation of empirical antimicrobial therapy. This study aimed to compare the de-escalation strategy with the continuation of an appropriate empirical treatment in those patients.

methodsThis was a multicenter non-blinded randomized noninferiority trial of patients with severe sepsis who were randomly assigned to de-escalation or continuation of empirical antimicrobial treatment. Recruitment began in February 2012 and ended in April 2013 in nine intensive care units (ICUs) in France. Patients with severe sepsis were assigned to de-escalation (n = 59) or continuation of empirical antimicrobial treatment (n = 57). The primary outcome was to measure the duration of ICU stay. We defined a noninferiority margin of 2 days. If the lower boundary of the 95 % confidence interval (CI) for the difference in patients assigned to the de-escalation group was less than 2 days, as compared with that of patients assigned to the continuation group, de-escalation was considered to be noninferior to the continuation strategy. Secondary outcomes included mortality at 90 days, occurrence of organ failure, number of superinfections, and number of days with antibiotics during the ICU stay.

resultsThe median duration of ICU stay was 9 [interquartile range (IQR) 5-22] days in the de-escalation group and 8 [IQR 4-15] days in the continuation group, respectively (P = 0.71). The mean difference was 3.4 (95 % CI -1.7 to 8.5). A superinfection occurred in 16 (27 %) patients in the de-escalation group and six (11 %) patients in the continuation group (P = 0.03). The numbers of antibiotic days were 9 [7-15] and 7.5 [6-13] in the de-escalation group and continuation group, respectively (P = 0.03). Mortality was similar in both groups.

conclusionAs compared to the continuation of the empirical antimicrobial treatment, a strategy based on de-escalation of antibiotics resulted in prolonged duration of ICU stay. However, it did not affect the mortality rate.

Indexed as

Withholding TreatmentAgedAnti-Bacterial AgentsFemaleFranceHumansIntensive Care UnitsLength of StayLinear ModelsMaleMicrobial Sensitivity TestsMiddle AgedMultivariate AnalysisProportional Hazards ModelsSepsisAnti-Bacterial Agents

Identifiers

What OpenQuestion holds

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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.