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

Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

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.

Study Overview

• Status: Terminated
• Conditions: Severe Sepsis
• Intervention / Treatment: Other: Procalcitonin level

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • ICU in J.Minjoz hospital
  • Bobigny, France, 93009
    • ICU in Avicenne hospital
  • Boulogne, France, 92100
    • ICU in Ambroise Paré hospital
  • Garches, France, 92380
    • ICU in Raymond Poincaré hospital
  • Montbeliard, France, 25200
    • ICU in André Boulloche hospital
  • Mulhouse Belfort, France, 90000
    • ICU in Centre hospitalier général
  • St Etienne, France, 42055
    • ICU in St Etienne hospital
  • Toulouse, France, 31059
    • ICU in Purpan hospital
  • Toulouse, France, 31059
    • ICU in Rangueil hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
rate of patients undergoing antibiotic treatment at D5.	at D5

Secondary Outcome Measures

Outcome Measure	Time Frame
evolution of the SOFA score between D0, D3 and D5.	D30

Collaborators and Investigators

• Sponsor: Brahms France
• Investigators: Principal Investigator: Djillali Annane, Professor, Raymond Poincaré hospital Garches-France

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): March 1, 2010

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Estimate): December 6, 2010
• Last Update Submitted That Met QC Criteria: December 3, 2010
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Keywords: safety; Procalcitonin; Sepsis; Antibiotic; SIRS; SOFA; PCT; Strategy; severe sepsis without obvious infection
• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Infections
• Other Study ID Numbers: PCT-F-2005-10