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

Not Applicable

Completed

• Conditions: Sepsis; Septic Shock; Severe Sepsis
• Interventions: Other: procalcitonin-guidance

• Registration Number: NCT01139489
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-08
• Study First Submitted QC: 2010-06-07
• Study First Posted: 2010-06-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-05
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1575

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 post-operative observation and/or on antibiotic prophylaxis with an estimated length of stay less then 24 hrs.
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
procalcitonin-guidance	procalcitonin-guidance	A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin

Primary Outcome Measures

Name	Time	Method
Mortality	1 year
Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy.	Between day 1 and D28

Secondary Outcome Measures

Name	Time	Method
Acquisition costs of procalcitonin	Between D1-D28	Expressed in euro's
Acquisition costs of antibiotics	Between D1-D28	Expressed in euro's
Length of ICU stay	Between D1 and D28

Trial Locations

Locations (1)

VU University medical center; 🇳🇱 Amsterdam, Netherlands