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

Amsterdam UMC, location VUmc

Status

Completed

Conditions

Severe Sepsis

Septic Shock

Sepsis

Treatments

Other: procalcitonin-guidance

Study type

Interventional

Funder types

Other

Identifiers

NCT01139489

VU University medical center

NTR1861 (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

1,575 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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