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

Primary Purpose

Severe Sepsis

Status
Terminated
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Procalcitonin level
Sponsored by
Brahms France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Severe Sepsis focused on measuring safety, Procalcitonin, PCT, SOFA, Sepsis, Antibiotic, Strategy, SIRS, severe sepsis without obvious infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ICU in J.Minjoz hospital
  • ICU in Avicenne hospital
  • ICU in Ambroise Paré hospital
  • ICU in Raymond Poincaré hospital
  • ICU in André Boulloche hospital
  • ICU in Centre hospitalier général
  • ICU in St Etienne hospital
  • ICU in Purpan hospital
  • ICU in Rangueil hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Procalcitonin level

physician's appreciation

Arm Description

duration of the antibiotic treatment guided by procalcitonin level

duration of the antibiotic treatment based on physician's appreciation

Outcomes

Primary Outcome Measures

rate of patients undergoing antibiotic treatment at D5.

Secondary Outcome Measures

evolution of the SOFA score between D0, D3 and D5.

Full Information

First Posted
December 1, 2009
Last Updated
December 3, 2010
Sponsor
Brahms France
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1. Study Identification

Unique Protocol Identification Number
NCT01025180
Brief Title
Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection
Acronym
Pro-SEPS
Official Title
Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Terminated
Why Stopped
65 patients were included after 2 years instead of 140
Study Start Date
December 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Brahms France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
safety, Procalcitonin, PCT, SOFA, Sepsis, Antibiotic, Strategy, SIRS, severe sepsis without obvious infection

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procalcitonin level
Arm Type
Other
Arm Description
duration of the antibiotic treatment guided by procalcitonin level
Arm Title
physician's appreciation
Arm Type
No Intervention
Arm Description
duration of the antibiotic treatment based on physician's appreciation
Intervention Type
Other
Intervention Name(s)
Procalcitonin level
Intervention Description
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
Primary Outcome Measure Information:
Title
rate of patients undergoing antibiotic treatment at D5.
Time Frame
at D5
Secondary Outcome Measure Information:
Title
evolution of the SOFA score between D0, D3 and D5.
Time Frame
D30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Djillali Annane, Professor
Organizational Affiliation
Raymond Poincaré hospital Garches-France
Official's Role
Principal Investigator
Facility Information:
Facility Name
ICU in J.Minjoz hospital
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
ICU in Avicenne hospital
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
ICU in Ambroise Paré hospital
City
Boulogne
ZIP/Postal Code
92100
Country
France
Facility Name
ICU in Raymond Poincaré hospital
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
ICU in André Boulloche hospital
City
Montbeliard
ZIP/Postal Code
25200
Country
France
Facility Name
ICU in Centre hospitalier général
City
Mulhouse Belfort
ZIP/Postal Code
90000
Country
France
Facility Name
ICU in St Etienne hospital
City
St Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
ICU in Purpan hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
ICU in Rangueil hospital
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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