IP Library Granted Patent US 7,820,652
Granted Patent B2
US 7,820,652 · App. 10/948,608 · Granted Oct 26, 2010

Regimen for the administration of rifamycin-class antibiotics

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Quick Facts
Patent No.
US 7,820,652
App. No.
10/948,608
Granted
Oct 26, 2010
Kind
B2
Abstract

The invention features an ascending dose regimen for the administration of rifamycin-class antibiotics. The dosing regimen can be used to treat bacterial infections and diseases related to infection.

Claims (27)

1. A method of treating bacterial infection in a patient, wherein said patient is already suffering from a bacterial infection, and, said method comprising administering rifalazil to said patient in ascending doses.

2. The method of claim 1 , wherein said ascending doses comprise:

a) an initial administration of an average daily dose for 4 to 14 days; and

b) following said initial administration, administration of two to four times said average daily dose for 4 to 14 days.

3. The method of claim 1 , wherein said ascending doses comprise:

a) an initial administration of an average daily dose for 4 to 14 days;

b) following said initial administration, administration of two times said average daily dose for a period of 4 to 14 days; and

c) following said period, administration of four times said average daily dose for 4 to 14 days.

4. The method of claim 1 , wherein said ascending doses comprise an average initial daily dose which is less than 80% of the average daily dose over any of the next two, three, four, or five subsequent dosing days.

5. The method of claim 1 , wherein said ascending doses comprise a dose administered on Day 1, said dose administered on Day 1 being less than 90% of the dose administered on any one of the next four dosing days.

6. The method of claim 1 , wherein said infection is selected from the group consisting of a community-acquired pneumonia, upper and lower respiratory tract infection, skin and soft tissue infection, bone and joint infection, hospital-acquired lung infection, acute bacterial otitis media, bacterial pneumonia, complicated infection, noncomplicated infection, pyelonephritis, intra-abdominal infection, deep-seated abcess, bacterial sepsis, central nervous system infection, bacteremia, wound infection, peritonitis, meningitis, infections after burn, urogenital tract infection, gastro-intestinal tract infection, pelvic inflammatory disease, endocarditis, and intravascular infection.

7. A method for prophylaxis against bacterial infection resulting from a surgical procedure or implantation of a prosthetic device, said method comprising administering to a patient in need thereof rifalazil in ascending doses.

8. The method of claim 1 , wherein said infection is by a Gram-positive bacterium.

9. The method of claim 8 , wherein said bacterium is a Gram-positive coccus.

10. The method of claim 9 , wherein said Gram-positive coccus is drug-resistant.

11. The method of claim 10 , wherein said infection is by a bacterium selected from the group consisting of S. aureus, S. epidermidis, S. pneumoniae, S. pyogenes, Enterococcus spp. , and M. catarrhalis.

12. The method of claim 1 , wherein said bacteria are selected from the group consisting of Streptococcus pneumoniae, Staphylococcus aureus, Streptococcus pyogenes , and Enterococcus spp.

13. The method of claim 1 , wherein said ascending doses comprise administration of rifalazil at a dose of less than 25 mg per week for 1-2 weeks followed by greater than 25 mg per week thereafter.

14. The method of claim 13 , wherein said ascending doses comprise adminisration of rifalazil at a dose of less than 10 mg per week for 1-2 weeks followed by greater than 10 mg per week thereafter.

15. The method of claim 14 , wherein said ascending doses comprise administration of rifalazil at a dose of less than 5 mg per week for 1-2 weeks followed by greater than 5 mg per week thereafter.

16. The method of claim 1 , wherein the rifalazil is administered orally.

17. A method for treating a patient having an infection of Clostridium difficile in said patient, said method comprising administering rifalazil in ascending doses to said patient in an amount effective to treat said infection.

18. A method for treating an infection of a bacterium having a multiplying form and a non-multiplying form, said method comprising administering to a patient (i) rifalazil; and (ii) a second antibiotic effective against the multiplying form of said bacterium, wherein said rifalazil is administered in an amount and for a duration effective to treat the non-multiplying form of said bacterium and the second antibiotic is administered in an amount and for a duration effective to treat said multiplying form of said bacterium and wherein rifalazil is administered in ascending doses.

19. The method of claim 18 , wherein said antibiotic effective against said multiplying form of said bacterium is administered to said patient in an amount and for a duration to reduce the presence of said bacterium in said patient to less than about 10 6 organisms/mL; and rifalazil is then administered to said patient in an amount and for a duration effective to reduce the presence of said bacterium to or below a level indicative that said infection has been treated.

20. A method of eradicating non-multiplying bacteria not eradicated in a patient following treatment with a first antibiotic, said method comprising administering rifalazil to said patient in an amount and for a duration effective to eradicate said non-multiplying bacteria in said patient, wherein said rifalazil is administered in ascending doses.

21. A method of treating a patient diagnosed as having a chronic disease associated with a bacterial infection caused by bacteria capable of establishing a non-multiplying form phase, said method comprising administering rifalazil to said patient in an amount and for a duration effective to treat said patient, wherein said rifalazil is administered in ascending doses.

22. A method of treating the cryptic phase of a bacterial infection, said method comprising administering rifalazil to said patient in an amount and for a duration effective to treat said cryptic phase of said bacterial infection, wherein said rifalazil is administered in ascending doses.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 25, 2008
From: FINN JR.,JOSEPH F., AS ASSIGNEE FOR THE BENEFIT OF CREDITORS OF ACTIVBIOTICS, INC.
To: ACTIVBIOTICS PHARMA LLC
Reel/Frame 020866/0584 →
RELEASE OF SECURITY INTEREST Recorded Apr 18, 2008
From: HORIZON TECHNOLOGY FUNDING COMPANY LLC
To: ACTIVBIOTICS, INC.
Reel/Frame 020835/0427 →
SECURITY AGREEMENT Recorded Jan 7, 2008
From: ACTIVBIOTICS, INC.
To: HORIZON TECHNOLOGY FUNDING COMPANY, LLC
Reel/Frame 020325/0299 →