Safety and Efficacy of Procalcitonin Guided Antibiotic Therapy in Adult Intensive Care Units (ICU's) (SAPS)
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|ClinicalTrials.gov Identifier: NCT01139489|
Recruitment Status : Completed
First Posted : June 8, 2010
Last Update Posted : January 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Sepsis Severe Sepsis Septic Shock||Other: procalcitonin-guidance||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1575 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Stop Antibiotics on Procalcitonin Guidance Study|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
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
- Mortality [ Time Frame: 28 days ]
- 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 ]
- Mortality [ Time Frame: 1 year ]
- Length of ICU stay [ Time Frame: Between D1 and D28 ]
- Acquisition costs of antibiotics [ Time Frame: Between D1-D28 ]Expressed in euro's
- Acquisition costs of procalcitonin [ Time Frame: Between D1-D28 ]Expressed in euro's
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139489
|VU University medical center|
|Amsterdam, Netherlands, 1081 HV|
|Principal Investigator:||Evelien de Jong, MSc||VU University Medical Center|