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

Sepsis Clinical Trial

— SAPS  

Official title:

Stop Antibiotics on Procalcitonin Guidance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01139489
• Other study ID #: VU University medical center
• Secondary ID: NTR1861
• Status: Completed
• Phase: N/A
• First received: March 8, 2010
• Last updated: January 5, 2016
• Start date: November 2009
• Est. completion date: August 2014

Study information

• Verified date: January 2016
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1575
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Severe Sepsis
• Toxemia

Intervention

Other:
• procalcitonin-guidance
If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.

Locations

Country	Name	City	State
Netherlands	VU University medical center	Amsterdam

Sponsors (15)

Lead Sponsor	Collaborator
VU University Medical Center	Atrium Medical Center, Bronovo Hospital, Canisius-Wilhelmina Hospital, Diakonessenhuis, Utrecht, Elisabeth-TweeSteden Ziekenhuis, Isala, Martini Hospital Groningen, Medical Center Haaglanden, Medisch Spectrum Twente, Slotervaart Hospital, St. Lucas Andreas Ziekenhuis Hospital, UMC Utrecht, University of Groningen, Westfriesgasthuis

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		28 days	Yes
Primary	Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy.		Between day 1 and D28	Yes
Primary	Mortality		1 year	Yes
Secondary	Length of ICU stay		Between D1 and D28	Yes
Secondary	Acquisition costs of antibiotics	Expressed in euro's	Between D1-D28	No
Secondary	Acquisition costs of procalcitonin	Expressed in euro's	Between D1-D28	No

External Links

•   Netherlands Trial Register