Procalcitonin and Antimicrobial Utilization in Critically Ill Cancer Patients With Sepsis (Pro-Can)

Introduction: Procalcitonin (PCT) is widely used as a biomarker to guide antibiotic use in critically ill patients with sepsis. There is limited data evaluating its role in cancer patients. We aimed to evaluate the impact of a PCT-guided algorithm on antibiotic prescription in critically ill cancer patients with sepsis.


Methods: The Pro-Can study was a randomized, controlled, single-blinded trial (ClinicalTrials.gov identifier: NCT04203524). We included adult patients treated in the intensive care unit (ICU) of a comprehensive cancer center. Eligible patients were those who had cancer, met the SEPSIS-3 criteria, were started on antibiotics for a suspected infection, and were expected to stay in the ICU for at least 48 hours. Patients were randomized to PCT-guided or blinded arm and stratified according to the presence of septic shock. PCT was measured daily, up to 5 days or until ICU transfer, whichever occurred first. For the PCT group, a PCT-guided algorithm was provided to guide the management of patients in the PCT group, but clinicians were allowed to override the algorithm, if clinically indicated. In the blinded group, all ICU clinicians were blinded to the PCT levels throughout the study. The primary outcome of the study was antibiotic days at day 28. We also evaluated antimicrobial consumption by the defined daily dose (DDD) of therapy.


Results: We enrolled 77 patients in the PCT-arm and 76 in the blinded arm. The mean age of patients was 58±14 (SD), 67% were males, and 74% had solid tumor while the remaining had hematological malignancies. The median (IQR) SOFA scores were 7 (6, 10) and 7 (5, 9) in the PCT-arm and blinded arm, respectively. PCT concentrations (ng/ml) at baseline were 3.4 (0.8, 16) and 3.4 (0.5, 26), in patients in the PCT-arm and blinded arm, respectively, but the rate of decline in PCT concentrations over time was greater in the PCT arm. The median (IQR) number of antibiotic treatment days was 8 (4-11) and 8 (5-13), (P= 0.463) and DDD for all antibiotics was 66 (34-111) versus 80.5 (51-144), (P=0.055), in the PCT and blinded arms, respectively.


Conclusions: In critically ill cancer patients with sepsis, PCT-guided management did not reduce the duration of antibiotic treatment or antimicrobial consumption.