De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

NCT01626612 | Completed Phase 3

• 2 other identifiers: 2011-002297-222011 -10
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Severe Sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Mortality in resuscitation

  24 months

• Lasted treatment antibiotic

  24 MONTHS

• Lasted mechanical ventilation(breakdown)

  24 months

• Lasted administration of catécholamines

  24 months

Study Arms (2)

a strategy based on de-escalation

EXPERIMENTAL

Procedure: streamlining of the empirical antimicrobial therapy

a conservative strategy

ACTIVE COMPARATOR

Procedure: continuation of the empirical antimicrobial therapy

Interventions

continuation of the empirical antimicrobial therapy PROCEDURE

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

a conservative strategy

streamlining of the empirical antimicrobial therapy PROCEDURE

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

a strategy based on de-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Related Publications (1)

• 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.

  PMID: 25091790 RESULT

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• BERNARD BELAIGUES

  Assistance Publique hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 25, 2012
• Study Start: February 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 7, 2026

Record last verified: 2015-04

Locations

FR (1)