Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection
NCT ID: NCT01025180
Last Updated: 2010-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
62 participants
INTERVENTIONAL
2007-12-31
2010-03-31
Brief Summary
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The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.
This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)
140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.
The primary outcome is the rate of patients undergoing antibiotic treatment at D5.
Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.
Duration of patient enrollment is 30 days.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Procalcitonin level
duration of the antibiotic treatment guided by procalcitonin level
Procalcitonin level
The duration of antibiotic treatment is based on PCT level:
* \< 0.25 ng/ml: antibiotic should be stopped
* 0.25 \< PCT \<0.5: antibiotic prescription is not recommended
* \> 0.5 ng/ml: antibiotic should be used
physician's appreciation
duration of the antibiotic treatment based on physician's appreciation
No interventions assigned to this group
Interventions
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Procalcitonin level
The duration of antibiotic treatment is based on PCT level:
* \< 0.25 ng/ml: antibiotic should be stopped
* 0.25 \< PCT \<0.5: antibiotic prescription is not recommended
* \> 0.5 ng/ml: antibiotic should be used
Eligibility Criteria
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Inclusion Criteria
* severe sepsis symptomatology
* at least 2 SIRS criteria
* no infectious etiology detected
* at least one organ deficiency
Exclusion Criteria
* pregnancy
* burned
* patients with therapeutic limitation
* recent surgery
* secondary neutropenia
18 Years
ALL
No
Sponsors
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Brahms France
INDUSTRY
Responsible Party
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Coordinator and Principal Investigator
Principal Investigators
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Djillali Annane, Professor
Role: PRINCIPAL_INVESTIGATOR
Raymond Poincaré hospital Garches-France
Locations
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ICU in J.Minjoz hospital
Besançon, , France
ICU in Avicenne hospital
Bobigny, , France
ICU in Ambroise Paré hospital
Boulogne, , France
ICU in Raymond Poincaré hospital
Garches, , France
ICU in André Boulloche hospital
Montbéliard, , France
ICU in Centre hospitalier général
Mulhouse Belfort, , France
ICU in St Etienne hospital
Saint-Etienne, , France
ICU in Purpan hospital
Toulouse, , France
ICU in Rangueil hospital
Toulouse, , France
Countries
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Other Identifiers
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PCT-F-2005-10
Identifier Type: -
Identifier Source: org_study_id