De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

This study is currently recruiting participants.
Verified June 2012 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01626612
First received: June 4, 2012
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Severe Sepsis
Procedure: continuation of the empirical antimicrobial therapy
Procedure: streamlining of the empirical antimicrobial therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • the length of stay [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    he deadline in days sold enters the diagnosis of sepsis engrave or toxic shock and the exit of resuscitation.


Secondary Outcome Measures:
  • Mortality in resuscitation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The arisen of the death during the initial phase of stay in resuscitation

  • Lasted treatment antibiotic [ Time Frame: 24 MONTHS ] [ Designated as safety issue: No ]
    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

  • Lasted mechanical ventilation(breakdown) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown)

  • Lasted administration of catécholamines [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The number of days without catécholamines during the stay in resuscitation


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626612

Contacts
Contact: MARC leone marc.leone@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: marc leone    04 91 96 86 50    marc.leone@ap-hm.fr   
Principal Investigator: marc leone         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01626612     History of Changes
Other Study ID Numbers: 2011-002297-22, 2011 -10
Study First Received: June 4, 2012
Last Updated: June 22, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014