Clinical trial NCT01025180: Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection
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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Severe Sepsis
Keywords: safety
Procalcitonin
PCT
SOFA
Sepsis
Antibiotic
Strategy
SIRS
severe sepsis without obvious infection
Lead sponsor: Brahms France
Sponsor class: INDUSTRY
First posted: 2009-12-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: rate of patients undergoing antibiotic treatment at D5.
timeFrame: at D5
Secondary outcomes:
measure: evolution of the SOFA score between D0, D3 and D5.
timeFrame: D30
Other outcomes:
Locations:
city: Besançon
country: France
facility: ICU in J.Minjoz hospital
city: Bobigny
country: France
facility: ICU in Avicenne hospital
city: Boulogne
country: France
facility: ICU in Ambroise Paré hospital
city: Garches
country: France
facility: ICU in Raymond Poincaré hospital
city: Montbeliard
country: France
facility: ICU in André Boulloche hospital
city: Mulhouse Belfort
country: France
facility: ICU in Centre hospitalier général
city: St Etienne
country: France
facility: ICU in St Etienne hospital
city: Toulouse
country: France
facility: ICU in Purpan hospital
city: Toulouse
country: France
facility: ICU in Rangueil hospital
Study officials:
affiliation: Raymond Poincaré hospital Garches-France
name: Djillali Annane, Professor
role: PRINCIPAL_INVESTIGATOR
References: