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

This study has been terminated.
(65 patients were included after 2 years instead of 140)
Sponsor:
Information provided by:
Brahms France
ClinicalTrials.gov Identifier:
NCT01025180
First received: December 1, 2009
Last updated: December 3, 2010
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Severe Sepsis
 Other: Procalcitonin level
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Sepsis
U.S. FDA Resources

Further study details as provided by Brahms France:

Primary Outcome Measures:
  • rate of patients undergoing antibiotic treatment at D5. [ Time Frame: at D5 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evolution of the SOFA score between D0, D3 and D5. [ Time Frame: D30 ] [ Designated as safety issue: Yes ]

Enrollment: 62
Study Start Date: December 2007
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01025180

Locations
France
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
Investigators
Principal Investigator: Djillali Annane, Professor Raymond Poincaré hospital Garches-France
  More Information

No publications provided

Responsible Party: Djillali Annane/ Professor, Coordinator and Principal Investigator
ClinicalTrials.gov Identifier: NCT01025180     History of Changes
Other Study ID Numbers: PCT-F-2005-10
Study First Received: December 1, 2009
Last Updated: December 3, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Brahms France:
safety
Procalcitonin
PCT
SOFA
Sepsis
 Antibiotic
Strategy
SIRS
severe sepsis without obvious infection

Additional relevant MeSH terms:
Sepsis
Toxemia
Infection
Systemic Inflammatory Response Syndrome
Inflammation
 Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013