Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's) (SAPS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Stop Antibiotics on Procalcitonin Guidance Study|
- Mortality [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. [ Time Frame: Between day 1 and D28 ] [ Designated as safety issue: Yes ]
- Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Length of ICU stay [ Time Frame: Between D1 and D28 ] [ Designated as safety issue: Yes ]
- Acquisition costs of antibiotics [ Time Frame: Between D1-D28 ] [ Designated as safety issue: No ]Expressed in euro's
- Acquisition costs of procalcitonin [ Time Frame: Between D1-D28 ] [ Designated as safety issue: No ]Expressed in euro's
|Study Start Date:||November 2009|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Active Comparator: procalcitonin-guidance
A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin
If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.
Other Name: PCT
No Intervention: standard-of-care
standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01139489
|VU University medical center|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator:||Evelien de Jong, MSc||VU University Medical Center|