De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

NCT ID: NCT01626612

Last Updated: 2015-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

a strategy based on de-escalation

Group Type: EXPERIMENTAL

streamlining of the empirical antimicrobial therapy

Intervention Type: PROCEDURE

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

a conservative strategy

Group Type: ACTIVE_COMPARATOR

continuation of the empirical antimicrobial therapy

Intervention Type: PROCEDURE

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

Interventions

continuation of the empirical antimicrobial therapy

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

Intervention Type: PROCEDURE

streamlining of the empirical antimicrobial therapy

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

Intervention Type: PROCEDURE

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2011 -10

Identifier Type: OTHER

Identifier Source: secondary_id

2011-002297-22

Identifier Type: -

Identifier Source: org_study_id