NCT01139489

Trial name or title	Safety and efficacy of procalcitonin guided antibiotic therapy in adult intensive care units (ICUs) (SAPS)
Methods	RCT
Participants	Inclusion criteria: Age over 18 years old Receiving antibiotics for no more than 24 hours for an assumed or proven infection Informed consent Exclusion criteria: Failure to obtain written consent to participate Patients receiving prolonged antibiotic therapies (> 3 weeks, e.g. endocarditis, cerebral/hepatic abscess) Patients with severe infections due to viruses or parasites (e.g. dengue, Toxoplasma gondii, Plasmodium spp.) Patients infected with Mycobacterium tuberculosis Patients entering the ICU for postoperative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 h Patients suffering from cystic fibrosis Severely immunocompromised patients such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (< 500 neutrophils per mL) or patients with solid organ transplantation Moribund patients
Interventions	Procalcitonin‐guided AB therapy
Outcomes	Primary outcome measures: 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 day 28) (designated as safety issue: Yes) Secondary outcome measures: Length of ICU stay (time frame: between day 1 and day 28) (designated as safety issue: Yes) Acquisition costs of antibiotics (time frame: between day 1 and day 28) (designated as safety issue: No), expressed in Euros Acquisition costs of procalcitonin (time frame: between day 1 and day 28) (designated as safety issue: No), expressed in Euros
Starting date	November 2009
Contact information	Contact: Albertus Beishuizen, Dr; beishuizen@vumc.nl
Notes	Quote: "This is a randomised 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)."