IP Library Granted Patent US 8,518,648
Granted Patent B2
US 8,518,648 · App. 12/161,330 · Granted Aug 27, 2013

Diagnostic method

Inventors: Lars Björck (Lund, SE); Bertil Christensson (Lund, SE); Heiko Herwald (Veberöd, SE); Adam Linder (Lund, SE); Per Åkesson (Lund, SE)
Assignee: Hansa Medical AB
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Quick Facts
Patent No.
US 8,518,648
App. No.
12/161,330
Granted
Aug 27, 2013
Kind
B2
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 (34)

1. A method of identifying whether or not an individual is at risk of developing severe sepsis, which method comprises:

measuring HBP (Heparin Binding Protein; Cationic Antimicrobial Protein 37; Azurocidin) in the individuals;

measuring the White Blood Cell count (WBC) or neutrophil count (NC) in the individual; and

calculating the HBP/WBC ratio or HBP/NC ratio respectively,

wherein an elevated level of HBP and either an elevated HBP/WC or an elevated HBP/NC ratio indicates that the individual is at risk of developing severe sepsis.

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

3. A method according to claim 2 , wherein the WBC or NC is measured in a blood sample taken from the individual.

4. A method according to claim 2 , wherein the level of HBP in said individual is elevated if the level of HBP in said fluid sample is greater than about 20 ng/ml.

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

6. A method according to claim 3 , 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 x 10 9 /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.

7. A method according to claim 3 , 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.

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

9. A method according to claim 8 , wherein the individual has a confirmed or suspected infection and/or displays one or more of the SIRS (Severe Inflammatory Response Syndrome) criteria.

10. A method according to claim 8 , wherein the individual has a confirmed or suspected infection and/or displays two or more of the SIRS criteria.

11. A method according to claim 9 or 10 , 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.

12. A method according to claim 11 , 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.

13. A method according to claim 11 , wherein the individual is a mammal.

14. The method of claim 13 wherein the mammal is a human.

15. 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 by measuring HBP (Heparin Binding Protein; Cationic Antimicrobial Protein 37; Azurocidin) in the individual, wherein an elevated level of HBP indicates that the individual is at risk of developing severe sepsis; 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.

16. The method of claim 15 wherein the agent suitable for the treatment of infection is an antibiotic.

17. The method of claim 16 wherein the antibiotic is a broad-spectrum antibiotic.

18. The method of claim 16 wherein the antibiotic is clindamycin.

19. The method of claim 2 , wherein the level of HBP in said individual is elevated if the level of HBP in said fluid sample is greater than about 15ng/ml.

20. The method according to claim 15 , wherein HBP is measured in a fluid sample taken from the individual.

21. The method according to claim 20 , wherein the level of HBP in said individual is elevated if the level of HBP in said fluid sample is greater than about 15 ng/ml.

22. The method according to claim 20 , wherein the level of HBP in said individual is elevated if the level of HBP in said fluid sample is greater than about 20 ng/ml.

23. The method according to claim 20 , wherein the level or concentration of HBP in the fluid sample is elevated if the level is increased by at least 2.5 fold relative to the baseline level or concentration of HBP.

24. The method according to claim 15 , wherein the individual is suspected of being at risk of developing severe sepsis.

25. The method according to claim 24 , wherein the individual has a confirmed or suspected infection and/or displays one or more of the SIRS (Severe Inflammatory Response Syndrome) criteria.

26. The method according to claim 25 , wherein the individual has a confirmed or suspected infection and/or displays two or more of the SIRS criteria.

27. The method according to claim 25 or 26 , 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.

28. The method according to claim 27 , wherein the individual is: immuno-compromised, a diabetic, a hospitalized patient with an intravenous line, a surgical wound, a surgical drain or a bedsore, or any combination thereof.

Assignments (2)
CHANGE OF NAME Recorded Jan 6, 2020
From: HANSA MEDICAL AB
To: HANSA BIOPHARMA AB
Reel/Frame 051485/0654 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 10, 2008
From: BJORCK, LARS; CHRISTENSSON, BERTIL; HERWALD, HEIKO; LINDER, ADAM; AKESSON, PER
To: HANSA MEDICAL AB
Reel/Frame 021810/0606 →
Priority Claims (1)
GB 0711327.7 · Jun 12, 2007 · national
Continuity (1)
Related Publication 20100305185A1 · Dec 2, 2010