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Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection (Pro-SEPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01025180
Recruitment Status : Terminated (65 patients were included after 2 years instead of 140)
First Posted : December 3, 2009
Last Update Posted : December 6, 2010
Information provided by:
Brahms France

Brief Summary:

A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

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.

Condition or disease Intervention/treatment Phase
Severe Sepsis Other: Procalcitonin level Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection
Study Start Date : December 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Sepsis

Arm Intervention/treatment
Procalcitonin level
duration of the antibiotic treatment guided by procalcitonin level
Other: 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

No Intervention: physician's appreciation
duration of the antibiotic treatment based on physician's appreciation

Primary Outcome Measures :
  1. rate of patients undergoing antibiotic treatment at D5. [ Time Frame: at D5 ]

Secondary Outcome Measures :
  1. evolution of the SOFA score between D0, D3 and D5. [ Time Frame: D30 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hospitalized in resuscitation ward
  • severe sepsis symptomatology
  • at least 2 SIRS criteria
  • no infectious etiology detected
  • at least one organ deficiency

Exclusion Criteria:

  • the presence of a pathogen agent or infectious centre clearly identified
  • pregnancy
  • burned
  • patients with therapeutic limitation
  • recent surgery
  • secondary neutropenia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01025180

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ICU in J.Minjoz hospital
Besançon, France, 25030
ICU in Avicenne hospital
Bobigny, France, 93009
ICU in Ambroise Paré hospital
Boulogne, France, 92100
ICU in Raymond Poincaré hospital
Garches, France, 92380
ICU in André Boulloche hospital
Montbeliard, France, 25200
ICU in Centre hospitalier général
Mulhouse Belfort, France, 90000
ICU in St Etienne hospital
St Etienne, France, 42055
ICU in Purpan hospital
Toulouse, France, 31059
ICU in Rangueil hospital
Toulouse, France, 31059
Sponsors and Collaborators
Brahms France
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Principal Investigator: Djillali Annane, Professor Raymond Poincaré hospital Garches-France
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Responsible Party: Djillali Annane/ Professor, Coordinator and Principal Investigator Identifier: NCT01025180    
Other Study ID Numbers: PCT-F-2005-10
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: December 6, 2010
Last Verified: December 2009
Keywords provided by Brahms France:
severe sepsis without obvious infection
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes