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

• Sponsor: Amsterdam UMC, location VUmc (Other)
• Overall Status: Completed
• CT.gov ID: NCT01139489
• Collaborator: UMC Utrecht (Other), Elisabeth-TweeSteden Ziekenhuis (Other), Diakonessenhuis, Utrecht (Other), Isala (Other), Atrium Medical Center (Other), Dijklander Ziekenhuis (Other), Bronovo Hospital (Other), Medical Center Haaglanden (Other), Slotervaart Hospital (Other), University of Groningen (Other), Martini Hospital Groningen (Other), Canisius-Wilhelmina Hospital (Other), Medisch Spectrum Twente (Other), St. Lucas Andreas Ziekenhuis Hospital (Other)
• Enrollment: 1,575
• Location: 1
• Arms: 2
• Duration (Months): 57
• Patients Per Site Per Month: 27.6

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis; Severe Sepsis; Septic Shock	Other: procalcitonin-guidance	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 1575 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Stop Antibiotics on Procalcitonin Guidance Study
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: procalcitonin-guidance A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin	Other: procalcitonin-guidance; If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.; Other Names: PCT
No Intervention: standard-of-care standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion

Outcome Measures

Primary Outcome Measures

1. Mortality [28 days]

2. Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy. [Between day 1 and D28]

3. Mortality [1 year]

Secondary Outcome Measures

1. Length of ICU stay [Between D1 and D28]

2. Acquisition costs of antibiotics [Between D1-D28]

   Expressed in euro's

3. Acquisition costs of procalcitonin [Between D1-D28]

   Expressed in euro's

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VU University medical center	Amsterdam		Netherlands	1081 HV

Sponsors and Collaborators

• Amsterdam UMC, location VUmc
• UMC Utrecht
• Elisabeth-TweeSteden Ziekenhuis
• Diakonessenhuis, Utrecht
• Isala
• Atrium Medical Center
• Dijklander Ziekenhuis
• Bronovo Hospital
• Medical Center Haaglanden
• Slotervaart Hospital
• University of Groningen
• Martini Hospital Groningen
• Canisius-Wilhelmina Hospital
• Medisch Spectrum Twente
• St. Lucas Andreas Ziekenhuis Hospital

Investigators

• Principal Investigator: Evelien de Jong, MSc, Amsterdam UMC, location VUmc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Evelien de Jong, drs, Amsterdam UMC, location VUmc
• ClinicalTrials.gov Identifier: NCT01139489
• Other Study ID Numbers: VU University medical center; NTR1861
• First Posted: Jun 8, 2010
• Last Update Posted: Jan 6, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Evelien de Jong, drs, Amsterdam UMC, location VUmc: Procalcitonin; antibiotic therapy; antibiotics; sepsis; infections; biomarker
• Additional relevant MeSH terms: Sepsis; Toxemia

Study Results

No Results Posted as of Jan 6, 2016