Procalcitonin and Antimicrobial Utilization in Critically Ill Cancer Patients with Sepsis

NCT04203524 | Terminated DMC

• 1 other identifier: 19KHCC11
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

Studies have demonstrated that the use of a procalcitonin (PCT)-guided algorithm in combination with clinical judgment was associated with reduced antibiotic use without impacting mortality or treatment failure. Though several studies have evaluated the use of PCT in critically ill patients, there are limited studies that evaluated PCT in patients with cancer and many of the currently available studies have excluded immune-compromised patients. This is a randomized controlled trial that aims to evaluate the impact of a procalcitonin-guided algorithm on antibiotic utilization in critically ill cancer patients with sepsis. In addition, the study aims to evaluate the predictive value of PCT for predicting mortality and positive cultures.

Conditions

Sepsis; Septic Shock; Neoplasm; Critical Illness

Keywords

Procalcitonin; Sepsis; Septic shock; Cancer; Critical illness

Outcome Measures

Primary Outcomes (2)

• Time to antibiotic cessation

  Time to antibiotic cessation at 28 days, hospital discharge, or death, whichever comes first after randomization

  28 days

• Number of antibiotic-free days

  Number of antibiotic-free days at day 28 after randomization

  28 days

Secondary Outcomes (1)

• Antibiotic utilization

  28 days

Other Outcomes (5)

• Antibiotic de-escalation

  28 days

• Predictive value of PCT for both mortality

  28 days

• Recurrence of infection

  28 days

Study Arms (2)

Procalcitonin Arm

EXPERIMENTAL

The medical team will be provided with a daily PCT for the patient, along with the PCT-guided algorithm that outlines the suggested management based on the PCT levels.

Diagnostic Test: Procalcitonin Levels

Control Arm

OTHER

Procalcitonin levels will be measured for those patients, but the medical team will be blinded from their results

Other: Control

Interventions

Procalcitonin Levels DIAGNOSTIC_TEST

Procalcitonin (PCT) will be measured within 48 hours of admission to the ICU or 48 hours of onset of sepsis (if developed during the ICU stay). In addition, the patients will have daily blood samples taken up to 5 days or until ICU transfer, whichever occurs first. A PCT-guided algorithm will be available to guide the management of patients in the PCT group.

Procalcitonin Arm

Control OTHER

Procalcitonin (PCT) will be measured within 48 hours of admission to the ICU or 48 hours of onset of sepsis (if developed during the ICU stay). In addition, the patients will have daily blood samples taken up to 5 days or until ICU transfer, whichever occurs first.The results of the PCT levels obtained will be blinded and all clinical team members will not be able to access the results.

Control Arm

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old
• Expected to remain in the ICU for at least 48 hours
• Patient meets the SEPSIS-3 criteria for sepsis defined as having a SOFA score change of 2 or more and suspected infection.
• Patient on antibiotics for suspected infection

You may not qualify if:

• Patient code is DNR
• Patient receiving antibiotics for surgical prophylaxis
• Consent cannot be obtained
• Patients who are expected to require antibiotics for more than 14 days
• Patients who have PCT levels ordered as part of their routine clinical care
• Patients who are followed by the Infectious Disease team.
• Patient with life expectancy \<24 hours.

Sponsors & Collaborators

• King Hussein Cancer Center: lead

Study Sites (1)

King Hussein Cancer Center

Amman, Jordan

Location

Related Publications (8)

• Shehabi Y, Sterba M, Garrett PM, Rachakonda KS, Stephens D, Harrigan P, Walker A, Bailey MJ, Johnson B, Millis D, Ding G, Peake S, Wong H, Thomas J, Smith K, Forbes L, Hardie M, Micallef S, Fraser JF; ProGUARD Study Investigators; ANZICS Clinical Trials Group. Procalcitonin algorithm in critically ill adults with undifferentiated infection or suspected sepsis. A randomized controlled trial. Am J Respir Crit Care Med. 2014 Nov 15;190(10):1102-10. doi: 10.1164/rccm.201408-1483OC.

  PMID: 25295709 BACKGROUND

• 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 BACKGROUND

• Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions: a systematic review of randomized controlled trials and recommendations for clinical algorithms. Arch Intern Med. 2011 Aug 8;171(15):1322-31. doi: 10.1001/archinternmed.2011.318.

  PMID: 21824946 BACKGROUND

• Andriolo BN, Andriolo RB, Salomao R, Atallah AN. Effectiveness and safety of procalcitonin evaluation for reducing mortality in adults with sepsis, severe sepsis or septic shock. Cochrane Database Syst Rev. 2017 Jan 18;1(1):CD010959. doi: 10.1002/14651858.CD010959.pub2.

  PMID: 28099689 BACKGROUND

• Paul M, Dickstein Y, Raz-Pasteur A. Antibiotic de-escalation for bloodstream infections and pneumonia: systematic review and meta-analysis. Clin Microbiol Infect. 2016 Dec;22(12):960-967. doi: 10.1016/j.cmi.2016.05.023. Epub 2016 Jun 6.

  PMID: 27283148 BACKGROUND

• Prkno A, Wacker C, Brunkhorst FM, Schlattmann P. Procalcitonin-guided therapy in intensive care unit patients with severe sepsis and septic shock--a systematic review and meta-analysis. Crit Care. 2013 Dec 11;17(6):R291. doi: 10.1186/cc13157.

  PMID: 24330744 BACKGROUND

• Soni NJ, Samson DJ, Galaydick JL, Vats V, Huang ES, Aronson N, Pitrak DL. Procalcitonin-guided antibiotic therapy: a systematic review and meta-analysis. J Hosp Med. 2013 Sep;8(9):530-40. doi: 10.1002/jhm.2067. Epub 2013 Aug 17.

  PMID: 23955852 BACKGROUND

• Wirz Y, Meier MA, Bouadma L, Luyt CE, Wolff M, Chastre J, Tubach F, Schroeder S, Nobre V, Annane D, Reinhart K, Damas P, Nijsten M, Shajiei A, deLange DW, Deliberato RO, Oliveira CF, Shehabi Y, van Oers JAH, Beishuizen A, Girbes ARJ, de Jong E, Mueller B, Schuetz P. Effect of procalcitonin-guided antibiotic treatment on clinical outcomes in intensive care unit patients with infection and sepsis patients: a patient-level meta-analysis of randomized trials. Crit Care. 2018 Aug 15;22(1):191. doi: 10.1186/s13054-018-2125-7.

  PMID: 30111341 BACKGROUND

MeSH Terms

Conditions

Sepsis; Shock, Septic; Neoplasms; Critical Illness

Condition Hierarchy (Ancestors)

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

Study Officials

• Lama H Nazer, PharmD

  King Hussein Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pharmacy Research and Staff Development/ Critical Care Clinical Pharmacy Specialist

Model Details: Randomized controlled study

Study Record Dates

• First Submitted: December 14, 2019
• First Posted: December 18, 2019
• Study Start: August 21, 2019
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: March 17, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)