De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis
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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) |
- 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.
- 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 |
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| Contact: MARC leone | marc.leone@ap-hm.fr |
| 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 | |
| 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 June 18, 2013