De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Completed

CT.gov ID

NCT01626612

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Severe Sepsis	Procedure: continuation of the empirical antimicrobial therapy Procedure: streamlining of the empirical antimicrobial therapy	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the length of stay [24 months]
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 [24 months]
The arisen of the death during the initial phase of stay in resuscitation
Lasted treatment antibiotic [24 MONTHS]
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) [24 months]
Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown)
Lasted administration of catécholamines [24 months]
The number of days without catécholamines during the stay in resuscitation

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hopitaux de Marseille	Marseille		France	13354

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: BERNARD BELAIGUES, Assistance Publique hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT01626612

Other Study ID Numbers:

2011-002297-22
2011 -10

First Posted:

Jun 25, 2012

Last Update Posted:

Apr 21, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Sepsis

Toxemia

Anti-Infective Agents

Anti-Bacterial Agents

Study Results

No Results Posted as of Apr 21, 2015