Use of procalcitonin (PCT) in risk stratification and prognosis of patients with a primary, non-infectious disease

Patent metadata

Field	Value
Publication number	US-10456364-B2
Application number	US-201113034752-A
Country	US
Kind code	B2
Filing date	Feb 25, 2011
Priority date	Aug 3, 2007
Publication date	Oct 29, 2019
Grant date	Oct 29, 2019

Abstract

Subject of the present invention are assays and in vitro methods for the in vitro diagnosis, prognosis and risk stratification of a patient having a primary, non-infectious disease, whereby the level of Procalcitonin (PCT) in a sample of a body fluid of the patient is indicative for the risk of the patient to contract a further disease or medical condition.

First claim

The invention claimed is:

1. A method comprising administering an antibiotic to a patient:
wherein the patient has a primary disease not being an infection;
wherein, before administering of the antibiotic, the patient has had a level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length determined and the level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length determined is between 0.02 and 0.1 ng/mL.

2. A method comprising:
determining a level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length in a patient;
wherein the patient has a level of said analyte which is between 0.02 and 0.1 ng/mL; wherein the patient has a primary disease not being an infection; and
after determining the level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length in the patient, administering an antibiotic to the patient.

3. A method according to claim 1 , wherein the level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length in the patient being between 0.02 and 0.1 ng/mL correlates to a risk of the patient to contract a cardiological disease or condition which has not yet been manifested and/or is not yet symptomatic.

4. A method according to claim 1 , wherein said primary disease is selected from cancer, diabetes, a chronic gastrointestinal disease, a chronic renal disease, hypertension, an orthopedic disease or a neurodegenerative disease.

5. The method according to claim 3 , wherein said level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length being between 0.02 and 0.1 ng/mL is indicative for a bacterial infection in the patient, which may facilitate, accelerate and/or enhance the risk of the patient contracting or acquiring said cardiological disease or condition.

6. The method according to claim 5 , wherein said bacterial infection is a local infection.

7. The method according to claim 3 , wherein the risk of contracting the cardiological disease or condition decreases when said patient is treated with the antibiotic.

8. The method according to claim 3 , wherein said further disease or condition is a cardiological disease or condition selected from the group consisting of atherosclerosis, acute coronary syndromes and heart failure.

9. The method according to claim 3 , further comprising correlating said level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length with a level of one or more additional prognostic biomarkers, whereby a combination of said level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length with said level of additional prognostic biomarker(s) increases predictive value of said level of analyte of procalcitonin or fragments thereof or the level of said related marker for said risk.

10. The method according to claim 9 , wherein one of said prognostic biomarker(s) is brain natriuretic peptide prohormone (proBNP) or a fragment thereof in a sample obtained from said patient.

11. The method according to claim 10 , wherein said fragment of proBNP is a 76 amino acid N-terminal fragment of brain natriuretic peptide (NT proBNP) or brain natriuretic peptide (BNP).

12. A method according to claim 9 , further comprising determining a level of one or more additional different prognostic biomarkers in a sample obtained from said patient, and correlating both said level of analyte of procalcitonin or fragments thereof and said level of one or more additional different prognostic biomarkers to said risk, whereby a combination of said level of analyte of procalcitonin or fragments thereof with said level of one or more additional different prognostic biomarkers increases predictive value of said level of analyte of procalcitonin or fragments thereof for said risk.

13. The method according to claim 12 , wherein the additional different prognostic biomarker is selected from a group consisting of troponin, myeloperoxidase, CRP, neopterin, GDF-15, ST2, cystatin-C, and the following peptides in the form of their mature peptides, precursors, pro-hormones and associated prohormone fragments: natriuretic peptides, adrenomedullin, endothelins, and vasopressin.

14. A method according to claim 9 , wherein the correlation between said level of analyte of procalcitonin or fragments thereof and said level of one or more additional prognostic biomarkers is conducted with a mathematical algorithm.

15. A method according to claim 12 , wherein the correlation between said level of analyte of procalcitonin or fragments thereof and said level of one or more additional different prognostic biomarkers is conducted with a mathematical algorithm.

16. The method of claim 1 , wherein, said level of analyte is between 0.03 and 0.1 ng/mL.

17. The method of claim 1 , wherein, said level of analyte is between 0.05 and 0.1 ng/mL.

18. A method according to claim 2 , wherein the level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length in the patient being between 0.02 and 0.1 ng/mL correlates to a risk of the patient to contract a cardiological disease or condition which has not yet been manifested and/or is not yet symptomatic.

19. A method according to claim 2 , wherein said primary disease is selected from cancer, diabetes, a chronic gastrointestinal disease, a chronic renal disease, hypertension, an orthopedic disease or a neurodegenerative disease.

20. The method according to claim 18 , wherein said level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length being between 0.02 and 0.1 ng/mL is indicative for a bacterial infection in the patient, which may facilitate, accelerate and/or enhance the risk of the patient contracting or acquiring said cardiological disease or condition.

21. The method according to claim 20 , wherein said bacterial infection is a local infection.

22. The method according to claim 18 , wherein the risk of contracting the cardiological disease or condition decreases when said patient is treated with the antibiotic.

23. The method according to claim 18 , wherein said further disease or condition is a cardiological disease or condition selected from the group consisting of atherosclerosis, acute coronary syndromes and heart failure.

24. The method according to claim 18 , further comprising correlating said level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length with a level of one or more additional prognostic biomarkers, whereby a combination of said level of analyte of procalcitonin or fragments thereof of at least 50 amino acids in length with said level of additional prognostic biomarker(s) increases predictive value of said level of analyte of procalcitonin or fragments thereof or the level of said related marker for said risk.

25. The method according to claim 24 , wherein one of said prognostic biomarker(s) is brain natriuretic peptide prohormone (proBNP) or a fragment thereof in a sample obtained from said patient.

26. The method according to claim 25 , wherein said fragment of proBNP is a 76 amino acid N-terminal fragment of brain natriuretic peptide (NT proBNP) or brain natriuretic peptide (BNP).

27. A method according to claim 24 , further comprising determining a level of one or more additional different prognostic biomarkers in

Assignees

• Struck Joachim
• Bergmann Andreas
• Brahms Gmbh

Inventors

• Struck Joachim
• Bergmann Andreas

Classifications

• A61P31/02

  Local antiseptics · CPC title

• A61P31/04

  Antibacterial agents · CPC title

• G01N33/6893

  related to diseases not provided for elsewhere · CPC title

• G01N2333/585

  Calcitonins · CPC title

• A61K31/00 Primary

  Medicinal preparations containing organic active ingredients · CPC title