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

NCT01139489 | Completed DMC

• 2 other identifiers: VU University medical centerNTR1861
• Study Type: interventional
• Target: 1,575
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis; Severe Sepsis; Septic Shock

Keywords

Procalcitonin; antibiotic therapy; antibiotics; sepsis; infections; biomarker

Outcome Measures

Primary Outcomes (3)

• Mortality

  28 days

• Consumption of antibiotics expressed as the Defined Daily Dosage and duration of antibiotic therapy expressed in days of therapy.

  Between day 1 and D28

• Mortality

  1 year

Secondary Outcomes (3)

• Length of ICU stay

  Between D1 and D28

• Acquisition costs of antibiotics

  Between D1-D28

• Acquisition costs of procalcitonin

  Between D1-D28

Study Arms (2)

procalcitonin-guidance

ACTIVE COMPARATOR

A daily advise to continue or stop antibiotics based on the measurement of the biomarker procalcitonin

Other: procalcitonin-guidance

standard-of-care

NO INTERVENTION

standard-of-care treatment of ICU infections based upon consensus guidelines and expert opinion

Interventions

procalcitonin-guidance OTHER

If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.

Also known as: PCT

procalcitonin-guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years old
• receiving antibiotics for no more than 24 hours for an assumed or proven infection
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

VU University medical center

Amsterdam, 1081 HV, Netherlands

Location

Related Publications (3)

• Shajiei A, Berends MS, Luz CF, van Oers JA, Harmsen HJM, Vos P, Klont R, Loef BG, Reidinga AC, Bormans-Russell L, Linsen K, Dormans T, Otten M, van der Bij A, Beishuizen A, de Lange DW, de Jong E, Nijsten MW. Impact of reduced antibiotic treatment duration on antimicrobial resistance in critically ill patients in the randomized controlled SAPS-trial. Front Med (Lausanne). 2023 Feb 2;10:1080007. doi: 10.3389/fmed.2023.1080007. eCollection 2023.

  PMID: 36817782 DERIVED

• de Jong E, van Oers JA, Beishuizen A, Vos P, Vermeijden WJ, Haas LE, Loef BG, Dormans T, van Melsen GC, Kluiters YC, Kemperman H, van den Elsen MJ, Schouten JA, Streefkerk JO, Krabbe HG, Kieft H, Kluge GH, van Dam VC, van Pelt J, Bormans L, Otten MB, Reidinga AC, Endeman H, Twisk JW, van de Garde EMW, de Smet AMGA, Kesecioglu J, Girbes AR, Nijsten MW, de Lange DW. Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial. Lancet Infect Dis. 2016 Jul;16(7):819-827. doi: 10.1016/S1473-3099(16)00053-0. Epub 2016 Mar 2.

  PMID: 26947523 DERIVED

• Assink-de Jong E, de Lange DW, van Oers JA, Nijsten MW, Twisk JW, Beishuizen A. Stop Antibiotics on guidance of Procalcitonin Study (SAPS): a randomised prospective multicenter investigator-initiated trial to analyse whether daily measurements of procalcitonin versus a standard-of-care approach can safely shorten antibiotic duration in intensive care unit patients--calculated sample size: 1816 patients. BMC Infect Dis. 2013 Apr 16;13:178. doi: 10.1186/1471-2334-13-178.

  PMID: 23590389 DERIVED

MeSH Terms

Conditions

Sepsis; Shock, Septic; Infections

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Evelien de Jong, MSc

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: drs

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: June 8, 2010
• Study Start: November 1, 2009
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

NL (1)