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NCT Number: NCT01626612

De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis

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.

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Key information

Conditions

Severe Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

continuation of the empirical antimicrobial therapy

Procedure

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

streamlining of the empirical antimicrobial therapy

Procedure

ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC

Primary outcomes

  1. the length of stay

    Time frame: 24 months

    he deadline in days sold enters the diagnosis of sepsis engrave or toxic shock and the exit of resuscitation.

Secondary outcomes

  1. Mortality in resuscitation

    Time frame: 24 months

    The arisen of the death during the initial phase of stay in resuscitation

  2. Lasted treatment antibiotic

    Time frame: 24 MONTHS

    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

  3. Lasted mechanical ventilation(breakdown)

    Time frame: 24 months

    Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown)

  4. Lasted administration of catécholamines

    Time frame: 24 months

    The number of days without catécholamines during the stay in resuscitation

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 25, 2012
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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