De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626612
• Other study ID #: 2011-002297-22
• Secondary ID: 2011 -10
• Status: Completed
• Phase: Phase 3
• First received: June 4, 2012
• Last updated: April 20, 2015
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis

Intervention

Procedure:
• continuation of the empirical antimicrobial therapy
ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC
• streamlining of the empirical antimicrobial therapy
ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mortality in resuscitation	The arisen of the death during the initial phase of stay in resuscitation	24 months	No
Secondary	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	No
Secondary	Lasted mechanical ventilation(breakdown)	Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown)	24 months	No
Secondary	Lasted administration of catécholamines	The number of days without catécholamines during the stay in resuscitation	24 months	No