PROCALCITONIN AS A DIAGNOSTIC AND PROGNOSTIC BIOMARKER IN CULTURE-NEGATIVE AND CULTURE-POSITIVE SEPSIS: A PROSPECTIVE OBSERVATIONAL STUDY
Main Article Content
Keywords
Procalcitonin, Sepsis, Biomarker, Mortality, Gram-negative bacteria
Abstract
Sepsis remains a major cause of morbidity and mortality worldwide, particularly in critically ill patients. Early diagnosis and prognostication are challenging due to non-specific clinical presentation and delayed microbiological confirmation. Procalcitonin (PCT), a biomarker released in response to bacterial infections, has emerged as a promising tool in the diagnosis and outcome prediction of sepsis.
Objectives: To evaluate the diagnostic utility of serum procalcitonin in differentiating controls, culture-negative sepsis, and culture-positive sepsis, and to assess its prognostic significance in relation to mortality and bacterial etiology.
Materials and Methods: This prospective observational study included 150 adult patients admitted to a tertiary care hospital. Participants were categorized into three groups: controls (n=35), culture-negative sepsis (n=45), and culture-positive sepsis (n=70). Serum PCT levels were measured at admission. Microbiological cultures were analyzed in culture-positive cases, and PCT values were correlated with bacterial pathogens and mortality outcomes.
Results: Mean PCT levels showed a significant stepwise increase from controls (0.92 ± 0.88 ng/mL) to culture-negative sepsis (12.96 ± 14.82 ng/mL) and culture-positive sepsis (18.21 ± 24.67 ng/mL; p<0.0001). Mortality was highest in culture-positive sepsis (34.3%). Non-survivors demonstrated significantly higher PCT levels compared to survivors. Gram-negative organisms, particularly Klebsiella pneumoniae and Acinetobacter baumannii, were associated with the highest PCT levels and mortality.
Conclusion: Serum procalcitonin is a valuable diagnostic and prognostic biomarker in sepsis. Elevated PCT levels correlate strongly with culture positivity, Gram-negative infections, and mortality, supporting its role in early risk stratification and clinical decision-making.
Objectives: To evaluate the diagnostic utility of serum procalcitonin in differentiating controls, culture-negative sepsis, and culture-positive sepsis, and to assess its prognostic significance in relation to mortality and bacterial etiology.
Materials and Methods: This prospective observational study included 150 adult patients admitted to a tertiary care hospital. Participants were categorized into three groups: controls (n=35), culture-negative sepsis (n=45), and culture-positive sepsis (n=70). Serum PCT levels were measured at admission. Microbiological cultures were analyzed in culture-positive cases, and PCT values were correlated with bacterial pathogens and mortality outcomes.
Results: Mean PCT levels showed a significant stepwise increase from controls (0.92 ± 0.88 ng/mL) to culture-negative sepsis (12.96 ± 14.82 ng/mL) and culture-positive sepsis (18.21 ± 24.67 ng/mL; p<0.0001). Mortality was highest in culture-positive sepsis (34.3%). Non-survivors demonstrated significantly higher PCT levels compared to survivors. Gram-negative organisms, particularly Klebsiella pneumoniae and Acinetobacter baumannii, were associated with the highest PCT levels and mortality.
Conclusion: Serum procalcitonin is a valuable diagnostic and prognostic biomarker in sepsis. Elevated PCT levels correlate strongly with culture positivity, Gram-negative infections, and mortality, supporting its role in early risk stratification and clinical decision-making.
References
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8. Phua J, Ngerng WJ, See KC, Tay CK, Kiong T, Lim HF, et al. Characteristics and outcomes of culture-negative versus culture-positive severe sepsis. Am J Respir Crit Care Med. 2013;188(8):973–980.
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13. Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993;341(8844):515–518.
14. Meisner M. Procalcitonin: experience with a new diagnostic tool for bacterial infection and systemic inflammation. J Lab Med. 1999;23:263–272.
15. Christ-Crain M, Müller B. Procalcitonin in bacterial infections—hype, hope, more or less? Swiss Med Wkly. 2005;135(31-32):451–460.
16. Schuetz P, Briel M, Christ-Crain M, Stolz D, Bouadma L, Wolff M, et al. Procalcitonin to guide initiation and duration of antibiotic treatment in acute respiratory infections. Lancet Infect Dis. 2012;12(9):777–789.
17. Jensen JU, Heslet L, Jensen TH, Espersen K, Steffensen P, Tvede M. Procalcitonin increase in early identification of critically ill patients at high risk of mortality. Crit Care Med. 2006;34(10):2596–2602.
18. Clec’h C, Ferriere F, Karoubi P, Fosse JP, Cupa M, Hoang P, et al. Diagnostic and prognostic value of procalcitonin in patients with septic shock. Crit Care. 2004;8(5):R154–R162.
19. Uzzan B, Cohen R, Nicolas P, Cucherat M, Perret GY. Procalcitonin as a diagnostic test for sepsis: a systematic review and meta-analysis. Crit Care Med. 2006;34(7):1996–2003.
20. Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, et al. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009;302(21):2323–2329.
21. Kumar S, Tripathi P, Gupta PK, Verma S, Singh R. Role of procalcitonin in early diagnosis and prognosis of sepsis in a tertiary care hospital. Indian J Crit Care Med. 2021;25(2):125–131.
22. Bassetti M, Giacobbe DR, Aliberti S, Barisione E, Centanni S, De Rosa FG, et al. Procalcitonin and community-acquired pneumonia: rationale and clinical applications. Clin Microbiol Infect. 2020;26(3):296–304.
23. Leli C, Ferranti M, Moretti A, Al Dhahab ZS, Cenci E, Mencacci A. Procalcitonin levels in gram-positive, gram-negative, and fungal bloodstream infections. Dis Markers. 2015;2015:701480.
24. Vandijck DM, Blot SI, De Waele JJ, Hoste EA, Vandewoude KH. De-escalation of antimicrobial therapy in sepsis. Intensive Care Med. 2007;33(9):1619–1625.
25. Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions. Arch Intern Med. 2011;171(15):1322–1331.
26. Kibe S, Adams K, Barlow G. Diagnostic and prognostic biomarkers of sepsis in critical care. J Antimicrob Chemother. 2011;66(Suppl 2):ii33–ii40.
27. van der Poll T, Opal SM. Host-pathogen interactions in sepsis. Lancet Infect Dis. 2008;8(1):32–43.
28. Garnacho-Montero J, Gutiérrez-Pizarraya A, Escoresca-Ortega A, Fernández-Delgado E, López-Sánchez JM. De-escalation of empirical therapy in severe sepsis and septic shock. Intensive Care Med. 2014;40(1):32–40.
29. Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, et al. Use of procalcitonin to reduce antibiotic exposure in patients with suspected bacterial infection. Lancet. 2010;375(9713):463–474.
30. Sager R, Kutz A, Mueller B, Schuetz P. Procalcitonin-guided diagnosis and antibiotic stewardship revisited. Am J Respir Crit Care Med. 2017;195(7):933–944.
2. Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, et al. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock. Intensive Care Med. 2017;43(3):304–377.
3. Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, et al. Global, regional, and national sepsis incidence and mortality, 1990–2017. Lancet. 2020;395(10219):200–211.
4. Fleischmann C, Scherag A, Adhikari NKJ, Hartog CS, Tsaganos T, Schlattmann P, et al. Assessment of Global Incidence and Mortality of Hospital-treated Sepsis. Am J Respir Crit Care Med. 2016;193(3):259–272.
5. Kumar A, Roberts D, Wood KE, Light B, Parrillo JE, Sharma S, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in septic shock. Crit Care Med. 2006;34(6):1589–1596.
6. Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, et al. 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med. 2003;31(4):1250–1256.
7. Lamy B, Roy P, Carret G, Flandrois JP, Delignette-Muller ML. What is the relevance of obtaining multiple blood samples for culture? Clin Microbiol Infect. 2002;8(4):255–260.
8. Phua J, Ngerng WJ, See KC, Tay CK, Kiong T, Lim HF, et al. Characteristics and outcomes of culture-negative versus culture-positive severe sepsis. Am J Respir Crit Care Med. 2013;188(8):973–980.
9. Dellit TH, Owens RC, McGowan JE Jr, Gerding DN, Weinstein RA, Burke JP, et al. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America guidelines for antimicrobial stewardship. Clin Infect Dis. 2007;44(2):159–177.
10. Pierrakos C, Vincent JL. Sepsis biomarkers: a review. Crit Care. 2010;14(1):R15.
11. Wacker C, Prkno A, Brunkhorst FM, Schlattmann P. Procalcitonin as a diagnostic marker for sepsis: a systematic review and meta-analysis. Lancet Infect Dis. 2013;13(5):426–435.
12. Becker KL, Nylén ES, White JC, Müller B, Snider RH Jr. Procalcitonin and the calcitonin gene family of peptides in inflammation, infection, and sepsis. Clin Chem. 2004;50(3):589–597.
13. Assicot M, Gendrel D, Carsin H, Raymond J, Guilbaud J, Bohuon C. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet. 1993;341(8844):515–518.
14. Meisner M. Procalcitonin: experience with a new diagnostic tool for bacterial infection and systemic inflammation. J Lab Med. 1999;23:263–272.
15. Christ-Crain M, Müller B. Procalcitonin in bacterial infections—hype, hope, more or less? Swiss Med Wkly. 2005;135(31-32):451–460.
16. Schuetz P, Briel M, Christ-Crain M, Stolz D, Bouadma L, Wolff M, et al. Procalcitonin to guide initiation and duration of antibiotic treatment in acute respiratory infections. Lancet Infect Dis. 2012;12(9):777–789.
17. Jensen JU, Heslet L, Jensen TH, Espersen K, Steffensen P, Tvede M. Procalcitonin increase in early identification of critically ill patients at high risk of mortality. Crit Care Med. 2006;34(10):2596–2602.
18. Clec’h C, Ferriere F, Karoubi P, Fosse JP, Cupa M, Hoang P, et al. Diagnostic and prognostic value of procalcitonin in patients with septic shock. Crit Care. 2004;8(5):R154–R162.
19. Uzzan B, Cohen R, Nicolas P, Cucherat M, Perret GY. Procalcitonin as a diagnostic test for sepsis: a systematic review and meta-analysis. Crit Care Med. 2006;34(7):1996–2003.
20. Vincent JL, Rello J, Marshall J, Silva E, Anzueto A, Martin CD, et al. International study of the prevalence and outcomes of infection in intensive care units. JAMA. 2009;302(21):2323–2329.
21. Kumar S, Tripathi P, Gupta PK, Verma S, Singh R. Role of procalcitonin in early diagnosis and prognosis of sepsis in a tertiary care hospital. Indian J Crit Care Med. 2021;25(2):125–131.
22. Bassetti M, Giacobbe DR, Aliberti S, Barisione E, Centanni S, De Rosa FG, et al. Procalcitonin and community-acquired pneumonia: rationale and clinical applications. Clin Microbiol Infect. 2020;26(3):296–304.
23. Leli C, Ferranti M, Moretti A, Al Dhahab ZS, Cenci E, Mencacci A. Procalcitonin levels in gram-positive, gram-negative, and fungal bloodstream infections. Dis Markers. 2015;2015:701480.
24. Vandijck DM, Blot SI, De Waele JJ, Hoste EA, Vandewoude KH. De-escalation of antimicrobial therapy in sepsis. Intensive Care Med. 2007;33(9):1619–1625.
25. Schuetz P, Chiappa V, Briel M, Greenwald JL. Procalcitonin algorithms for antibiotic therapy decisions. Arch Intern Med. 2011;171(15):1322–1331.
26. Kibe S, Adams K, Barlow G. Diagnostic and prognostic biomarkers of sepsis in critical care. J Antimicrob Chemother. 2011;66(Suppl 2):ii33–ii40.
27. van der Poll T, Opal SM. Host-pathogen interactions in sepsis. Lancet Infect Dis. 2008;8(1):32–43.
28. Garnacho-Montero J, Gutiérrez-Pizarraya A, Escoresca-Ortega A, Fernández-Delgado E, López-Sánchez JM. De-escalation of empirical therapy in severe sepsis and septic shock. Intensive Care Med. 2014;40(1):32–40.
29. Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, et al. Use of procalcitonin to reduce antibiotic exposure in patients with suspected bacterial infection. Lancet. 2010;375(9713):463–474.
30. Sager R, Kutz A, Mueller B, Schuetz P. Procalcitonin-guided diagnosis and antibiotic stewardship revisited. Am J Respir Crit Care Med. 2017;195(7):933–944.
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Published
Jan 29, 2026
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How to Cite
Dr Mayank Kumar, Dr Gaurav Kumar, Dr Ranvijay Singh, Dr Paras Kharbanda, & Dr Snehanshu Shukla. (2026). PROCALCITONIN AS A DIAGNOSTIC AND PROGNOSTIC BIOMARKER IN CULTURE-NEGATIVE AND CULTURE-POSITIVE SEPSIS: A PROSPECTIVE OBSERVATIONAL STUDY. Journal of Population Therapeutics and Clinical Pharmacology, 33(1), 809-817. https://doi.org/10.53555/em64a866
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Author Biographies
Dr Mayank Kumar
Associate Professor1*, Department of Pathology, Rajarshi Dashrath Autonomous State Medical College, Ayodhya, Uttar Pradesh, India.
Dr Gaurav Kumar
Associate Professor2, Department of Microbiology, Rajarshi Dashrath Autonomous State Medical College, Ayodhya, Uttar Pradesh, India.
Dr Ranvijay Singh
Associate Professor3, Department of Transfusion Medicine, Rajarshi Dashrath Autonomous State Medical College, Ayodhya, Uttar Pradesh, India.
Dr Paras Kharbanda
Professor4, Department of Pathology, Rajarshi Dashrath Autonomous State Medical College, Ayodhya, Uttar Pradesh, India.
Dr Snehanshu Shukla
Professor5, Department of Microbiology, Rajarshi Dashrath Autonomous State Medical College, Ayodhya, Uttar Pradesh, India.
How to Cite
Dr Mayank Kumar, Dr Gaurav Kumar, Dr Ranvijay Singh, Dr Paras Kharbanda, & Dr Snehanshu Shukla. (2026). PROCALCITONIN AS A DIAGNOSTIC AND PROGNOSTIC BIOMARKER IN CULTURE-NEGATIVE AND CULTURE-POSITIVE SEPSIS: A PROSPECTIVE OBSERVATIONAL STUDY. Journal of Population Therapeutics and Clinical Pharmacology, 33(1), 809-817. https://doi.org/10.53555/em64a866
