DIAGNOSTIC METHOD

• US 20100305185A1
• Filed: 06/12/2008
• Published: 12/02/2010
• Est. Priority Date: 06/12/2007
• Status: Active Grant

• Current Assignee: Hansa Biopharma AB
• Original Assignee: Hansa Medical AB
• Inventors: Herwald, Heiko, Åkesson, Per, Christensson, Bertil, Linder, Adam, Björck, Lars
• Granted Patent: US 8,518,648 B2
• Time in Patent Office: Days
• US Class Current: 514/422
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: G01N 2800/26 Infectious diseases, e.g. generalised sepsis
• CPC Class Codes: G01N 33/569 for microorganisms, e.g. protozoa, bacteria, viruses
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

It has been demonstrated that the level of HBP increases in individuals that subsequently develop severe sepsis. Accordingly, the level of HBP, HBP/WBC ratio or HBP/NC ratio in an individual can be used to determine whether or not an individual is at risk of developing severe sepsis.

Claims

1. A method of identifying whether or not an individual is at risk of developing severe sepsis, which method comprises measuring HBP in the individual and thereby determining whether or not the individual is at risk of developing severe sepsis.

2. A method according to claim 1, wherein the HBP is measured in a fluid sample taken from the individual.

3. A method according to claim 1 or 2, further comprising measuring the White Blood Cell count (WBC) or neutrophil count (NC) in the individual, calculating the HBP/WBC ratio or HBP/NC ratio respectively, and thereby determining whether or not the individual is at risk of developing severe sepsis.

4. A method according to claim 3, wherein the WBC or NC is measured in a blood sample taken from the individual.

5. A method according to claim 2, wherein determining whether or not the individual is at risk of developing severe sepsis comprises determining whether or not the concentration of HBP is greater than 20 ng/ml in the fluid sample.

6. A method according to claim 2, wherein the level or concentration of HBP in the fluid sample is increased by at least 2.5 fold relative to the baseline level or concentration of HBP.

7. A method according to claim 4, wherein, when the concentration of HBP in the fluid sample is measured in ng/ml and the WBC in the blood sample is measured in number of cells x10⁹/l, determining whether or not the individual is at risk of developing severe sepsis comprises determining whether or not the HBP/WBC ratio is greater than 2.

8. A method according to claim 4, wherein the HBP/WBC ratio or HBP/NC ratio in the blood sample is increased by at least 2.5 fold relative to the baseline HBP/WBC ratio or HBP/NC ratio respectively.

9. A method according to claim 1, wherein the individual is suspected of being at risk of developing severe sepsis.

10. A method according to claim 9, wherein the individual has a confirmed or suspected infection and/or displays one or more of the SIRS criteria.

11. A method according to claim 9, wherein the individual has a confirmed or suspected infection and/or displays two or more of the SIRS criteria.

12. A method according to claim 10 or 11, wherein the confirmed or suspected infection affects:

the lungs;

the respiratory tract;

the liver;

the kidneys;

the urinary tract;

the skin (cutaneous and subcutaneous);

the heart;

the stomach;

the intestines;

the blood;

the bones;

the joints or any combination thereof.

13. A method according to claim 12, wherein the individual is:

immuno-compromised;

a diabetic;

a hospitalised patient with an intravenous line, a surgical wound, a surgical drain or a bedsore;

or any combination thereof.

14. A method according to claim 12, wherein the individual is a mammal.

15. The method of claim 14 wherein the mammal is a human.

18. A method of reducing the risk of an individual developing severe sepsis, comprising;

(i) determining whether or not an individual is at risk of developing severe sepsis using a method according to claim 1; and

(ii) administering to an individual identified in (i) as at risk, a therapeutically effective amount of an agent suitable for the treatment of infection and/or intravenous fluids.

19. The method of claim 18 wherein the agent suitable for the treatment of infection is an antibiotic.

20. The method of claim 19 wherein the antibiotic is a broad-spectrum antibiotic.

21. The method of claim 19 wherein the antibiotic is clindamycin.

23. The kit of claim 21 additionally comprising means for the measurement of the WBC in an individual.

16. An agent for the detection of HBP for use in determining whether or not an individual is at risk of developing severe sepsis.

17. An agent according to claim 16 wherein the agent comprises an HBP-specific antibody.

22. A test kit for use in a method for determining whether or not an individual is at risk of developing severe sepsis, which test kit comprises an agent for the detection of HBP in an individual.