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

Phase 4

Terminated

• Conditions: Severe Sepsis
• Interventions: Other: Procalcitonin level

• Registration Number: NCT01025180
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Status Verified: 2009-12
• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2010-01
• Study Completion: 2010-03
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Procalcitonin level	Procalcitonin level	duration of the antibiotic treatment guided by procalcitonin level

Primary Outcome Measures

Name	Time	Method
rate of patients undergoing antibiotic treatment at D5.	at D5

Secondary Outcome Measures

Name	Time	Method
evolution of the SOFA score between D0, D3 and D5.	D30

Trial Locations

Locations (9)

ICU in Centre hospitalier général; 🇫🇷 Mulhouse Belfort, France

ICU in Avicenne hospital; 🇫🇷 Bobigny, France

ICU in Raymond Poincaré hospital; 🇫🇷 Garches, France

ICU in Ambroise Paré hospital; 🇫🇷 Boulogne, France

ICU in J.Minjoz hospital; 🇫🇷 Besançon, France

ICU in André Boulloche hospital; 🇫🇷 Montbeliard, France

ICU in Purpan hospital; 🇫🇷 Toulouse, France

ICU in St Etienne hospital; 🇫🇷 St Etienne, France

ICU in Rangueil hospital; 🇫🇷 Toulouse, France