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

This study has been completed.
Sponsor:
Collaborators:
UMC Utrecht
Elisabeth-TweeSteden Ziekenhuis
Diakonessenhuis, Utrecht
Isala
Atrium Medical Center
Westfriesgasthuis
Bronovo Hospital
Medical Center Haaglanden
Slotervaart Hospital
University of Groningen
Martini Hospital Groningen
Canisius-Wilhelmina Hospital
Medisch Spectrum Twente
St. Lucas Andreas Ziekenhuis Hospital
Information provided by (Responsible Party):
Evelien de Jong, VU University Medical Center
ClinicalTrials.gov Identifier:
NCT01139489
First received: March 8, 2010
Last updated: January 5, 2016
Last verified: January 2016
  Purpose
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 Intervention
Sepsis
Severe Sepsis
Septic Shock
Other: procalcitonin-guidance

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stop Antibiotics on Procalcitonin Guidance Study

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

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 D28 ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Length of ICU stay [ Time Frame: Between D1 and D28 ] [ Designated as safety issue: Yes ]
  • Acquisition costs of antibiotics [ Time Frame: Between D1-D28 ] [ Designated as safety issue: No ]
    Expressed in euro's

  • Acquisition costs of procalcitonin [ Time Frame: Between D1-D28 ] [ Designated as safety issue: No ]
    Expressed in euro's


Enrollment: 1575
Study Start Date: November 2009
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: PCT
No Intervention: standard-of-care
standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01139489

Locations
Netherlands
VU University medical center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
UMC Utrecht
Elisabeth-TweeSteden Ziekenhuis
Diakonessenhuis, Utrecht
Isala
Atrium Medical Center
Westfriesgasthuis
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 VU University Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Evelien de Jong, drs, VU University Medical Center
ClinicalTrials.gov Identifier: NCT01139489     History of Changes
Other Study ID Numbers: VU University medical center  NTR1861 
Study First Received: March 8, 2010
Last Updated: January 5, 2016
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by VU University Medical Center:
Procalcitonin
antibiotic therapy
antibiotics
sepsis
infections
biomarker

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcitonin
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016