Clinical trial NCT01626612: De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis
Official title: De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Severe Sepsis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: the length of stay
timeFrame: 24 months
Secondary outcomes:
measure: Mortality in resuscitation
timeFrame: 24 months
measure: Lasted treatment antibiotic
timeFrame: 24 MONTHS
measure: Lasted mechanical ventilation(breakdown)
timeFrame: 24 months
measure: Lasted administration of catécholamines
timeFrame: 24 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique hôpitaux de Marseille
name: BERNARD BELAIGUES
role: STUDY_DIRECTOR
References: