NCT01139489

Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's)

Stop Antibiotics on Procalcitonin Guidance Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,575 (actual)
• Sponsor: Amsterdam UMC, location VUmc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial comparing standard-of-care therapy of infections in critically ill patients with a procalcitonin-guided approach evaluating efficacy (antibiotics consumption) and safety (mortality).

Detailed description

Antibiotics are prescribed widely in intensive care units and are linked with high costs and the occurence of antimicrobial (multi)resistance. The optimal duration of antibiotic treatment is poorly known and often based on consensus guidelines. SAPS is a multicenter, prospective, randomized, controlled open-label trial evaluating the equivalence/efficacy and safety of procalcitonin-guided treatment of infections in ICU patients versus a standard-of-care approach. All patients that are admitted to the ICU and for whom systemic antibiotics are prescribed for presumed or proven bacterial infections are eligible for this trial. Patients will be randomized and stratified according to clinical diagnosis of severe sepsis and septic shock. Any patient over the age of 18, admitted to the ICU and receiving antibiotics for an assumed infection can be enrolled into this trial. Informed consent has to be obtained in writing from the patient of his/her relatives prior to inclusion. In the intervention group daily procalcitonin levels be performed and will generate a non-binding stopping advice when predefined stopping-rules have been reached. The ultimate decision to stop antibiotics will be at the discretion of the physician in both groups.

Conditions

• Sepsis
• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
OTHER	procalcitonin-guidance	If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.

Timeline

• Start date: 2009-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2010-06-08
• Last updated: 2016-01-06

Locations

1 site across 1 country: Netherlands