Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011 -10 | Other Identifier | AP HM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| a strategy based on de-escalation | Experimental |
| |
| a conservative strategy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| continuation of the empirical antimicrobial therapy | Procedure | ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality in resuscitation | The arisen of the death during the initial phase of stay in resuscitation | 24 months |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | 13354 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25091790 | Result | Leone M, Bechis C, Baumstarck K, Lefrant JY, Albanese J, Jaber S, Lepape A, Constantin JM, Papazian L, Bruder N, Allaouchiche B, Bezulier K, Antonini F, Textoris J, Martin C; AZUREA Network Investigators. De-escalation versus continuation of empirical antimicrobial treatment in severe sepsis: a multicenter non-blinded randomized noninferiority trial. Intensive Care Med. 2014 Oct;40(10):1399-408. doi: 10.1007/s00134-014-3411-8. Epub 2014 Aug 5. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| streamlining of the empirical antimicrobial therapy | Procedure | ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC |
|
| 24 MONTHS |
| Lasted mechanical ventilation(breakdown) | Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown) | 24 months |
| Lasted administration of catécholamines | The number of days without catécholamines during the stay in resuscitation | 24 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |