Severe SepsisPhase 3NCT01626612
De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis
A Phase 3 study testing continuation of the empirical antimicrobial therapy and streamlining of the empirical antimicrobial therapy in people with Severe Sepsis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- continuation of the empirical antimicrobial therapy and streamlining of the empirical antimicrobial therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Jul 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)
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
- Being tested
- continuation of the empirical antimicrobial therapy, streamlining of the empirical antimicrobial therapy
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuation of the empirical antimicrobial therapyProcedure or surgery
ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC
streamlining of the empirical antimicrobial therapyProcedure or surgery
ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC
| Study group | Role | What they receive |
|---|---|---|
| a strategy based on de-escalation | Experimental | Not described Receives: Procedure: streamlining of the empirical antimicrobial therapy |
| a conservative strategy | Active comparator | Not described Receives: Procedure: continuation of the empirical antimicrobial therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the length of stay
he deadline in days sold enters the diagnosis of sepsis engrave or toxic shock and the exit of resuscitation.
Measured: 24 months
Secondary outcomes (4)
Mortality in resuscitation
The arisen of the death during the initial phase of stay in resuscitation
Measured: 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
Measured: 24 MONTHS
Lasted mechanical ventilation(breakdown)
Deadline in days sold between the implementation and the stop(ruling) of the mechanical ventilation(breakdown)
Measured: 24 months
Lasted administration of catécholamines
The number of days without catécholamines during the stay in resuscitation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionApr 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626612
- Sponsor's protocol ID
- 2011-002297-22
- Other IDs
- 2011 -10
- Status last verified
- Apr 2015
- First submitted
- 4 Jun 2012
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25091790
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- De-escalation of Empirical Antimicrobial Therapy Study in Severe Sepsis: A Randomized Clinical Trial (DEA Study)
- ClinicalTrials.gov ID
- NCT01626612
- Acronym / sponsor ID
- 2011-002297-22
- Conditions
- Severe Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a strategy based on de-escalation | Experimental | Procedure: streamlining of the empirical antimicrobial therapy |
| a conservative strategy | Active comparator | Procedure: continuation of the empirical antimicrobial therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| continuation of the empirical antimicrobial therapyALL THE ANTIBACTERIAL IN WORN SYSTEMATIC | Procedure or surgery | a conservative strategy |
| streamlining of the empirical antimicrobial therapyALL THE ANTIBACTERIAL IN WORN SYSTEMATIC | Procedure or surgery | a strategy based on de-escalation |
Primary outcome
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.
4 secondary outcomes
Mortality in resuscitation
Time frame: 24 months
Lasted treatment antibiotic
Time frame: 24 MONTHS
Lasted mechanical ventilation(breakdown)
Time frame: 24 months
Lasted administration of catécholamines
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Results publication: PubMed 25091790Leone 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing continuation of the empirical antimicrobial therapy and streamlining of the empirical antimicrobial therapy in people with Severe Sepsis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the length of stay (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626612, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.