Clinical trial · Interventional
Procalcitonin and Antimicrobial Utilization in Critically Ill Cancer Patients with Sepsis
Impact of a Procalcitonin-Guided Algorithm on Antimicrobial Utilization in Critically Ill Cancer Patients with Sepsis: a Randomized Controlled Study (Pro-Can)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No significant differences between 2 study arms
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Critical Illness | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Sepsis | — | UNRESOLVED | — |
| Septic Shock | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Other | — | UNRESOLVED |
| Procalcitonin Levels | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Procalcitonin Arm
- description
- 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.
- interventionNames
- Diagnostic Test: Procalcitonin Levels
- type
- OTHER
- label
- Control Arm
- description
- Procalcitonin levels will be measured for those patients, but the medical team will be blinded from their results
- interventionNames
- Other: Control
Primary outcomes (2)
- measure
- Time to antibiotic cessation
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (8)
- BACKGROUNDShehabi 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
- BACKGROUNDde 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
- BACKGROUNDSchuetz 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
- BACKGROUNDAndriolo 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
- BACKGROUNDPaul 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