De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

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

Rational: Severe sepsis is one of the leading cause of mortality in intensive care unit patients. Early initiation of an appropriate empirical antimicrobial therapy is associated with improved outcomes. In order to avoid an increase of selection pressure and the emergence of multidrug resistant pathogens, guidelines recommend to streamline the antimicrobial therapy after the identification of the pathogen responsible for infection. This strategy has been evaluated in several observational studies. However, at the bedside, few randomized clinical trials tested this strategy prospectively.

Method: the investigators conduct a randomized clinical trial comparing a strategy based on de-escalation (streamlining of the empirical antimicrobial therapy) and a conservative strategy (continuation of the empirical antimicrobial therapy). The investigators first aim was to show that a strategy based on de-escalation is not inferior to a conservative strategy in terms of intensive care unit length of stay. Secondary aims are to compare the rate of mortality rate, the emergence of multidrug resistant pathogens, and the feasibility of de-escalation. The study is performed in nine intensive care units from four institutions, and 120 patients are required to validate the investigators hypothesis. New technologies for the rapid diagnosis of severe infections are investigated in an ancillary study.

Study Overview

• Status: Completed
• Conditions: Severe Sepsis
• Intervention / Treatment: Procedure: streamlining of the empirical antimicrobial therapy; Procedure: continuation of the empirical antimicrobial therapy

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13354
    • Assistance Publique Hopitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Major Subject;
• Subject having a sepsis engraves(burns) defined according to the following criteria during the initiation of the probability antibiotic treatment:
• Criteria of SIRS [ 14 ],
• And a suspected infection,
• And a failure of organ: low blood pressure, respiratory failure, coma, hepatic insufficiency, renal insufficiency, thrombopénia, spontaneous extension of the TCA,
• Subject for which an antibiotic treatment was begun within 6 hours following the diagnosis of sepsis engraves(burns);
• Subject for which a taking with microbiological aim was made within 48 hours following the diagnosis of sepsis

Exclusion Criteria:

• Minor Subject, pregnant or breast-feeding woman;
• Neutropénia (PN < 1000 / mm3);
• Absence of identification of a microorganism in the microbiological examinations;
• Absence of Social Security;
• Subject deprived of freedom or under guardianship;
• Subject for which the lit(enlightened) consent is not collected(taken in) (itself and/or reliable person).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a strategy based on de-escalation	Procedure: streamlining of the empirical antimicrobial therapy; ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC
Active Comparator: a conservative strategy	Procedure: continuation of the empirical antimicrobial therapy; ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the length of stay	he deadline in days sold enters the diagnosis of sepsis engrave or toxic shock and the exit of resuscitation.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in resuscitation	The arisen of the death during the initial phase of stay in resuscitation	24 months
Lasted treatment antibiotic	Deadline in days between the beginning of the initiation of the treatment(processing) antibiotic and the 1st day when the subject is not any more handled by antibiotic	24 MONTHS
Lasted mechanical ventilation(breakdown)	Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown)	24 months
Lasted administration of catécholamines	The number of days without catécholamines during the stay in resuscitation	24 months

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: BERNARD BELAIGUES, Assistance Publique Hopitaux de Marseille

Publications and helpful links

General Publications

• Leone M, Bechis C, Baumstarck K, Lefrant JY, Albanese J, Jaber S, Lepape A, Constantin JM, Papazian L, Bruder N, Allaouchiche B, Bezulier K, Antonini F, Textoris J, Martin C; AZUREA Network Investigators. De-escalation versus continuation of empirical antimicrobial treatment in severe sepsis: a multicenter non-blinded randomized noninferiority trial. Intensive Care Med. 2014 Oct;40(10):1399-408. doi: 10.1007/s00134-014-3411-8. Epub 2014 Aug 5.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: June 4, 2012
• First Submitted That Met QC Criteria: June 22, 2012
• First Posted (Estimated): June 25, 2012

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathological Conditions, Signs and Symptoms; Sepsis; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 2011-002297-22; 2011 -10 (Other Identifier: AP HM)