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

Severe Sepsis Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01025180
• Other study ID #: PCT-F-2005-10
• Status: Terminated
• Phase: Phase 4
• First received: December 1, 2009
• Last updated: December 3, 2010
• Start date: December 2007
• Est. completion date: March 2010

Study information

• Verified date: December 2009
• Source: Brahms France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: March 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
France	ICU in J.Minjoz hospital	Besançon
France	ICU in Avicenne hospital	Bobigny
France	ICU in Ambroise Paré hospital	Boulogne
France	ICU in Raymond Poincaré hospital	Garches
France	ICU in André Boulloche hospital	Montbeliard
France	ICU in Centre hospitalier général	Mulhouse Belfort
France	ICU in St Etienne hospital	St Etienne
France	ICU in Purpan hospital	Toulouse
France	ICU in Rangueil hospital	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Brahms France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of patients undergoing antibiotic treatment at D5.		at D5	Yes
Secondary	evolution of the SOFA score between D0, D3 and D5.		D30	Yes