Granted Patent B2

US 10,561,675 · App. 13/843,579 · Granted Feb 18, 2020

Abstract

Claims (18)

1. A method for treating a bacterial infection in a human, comprising administering to a subject in need thereof a composition comprising Compound I or a pharmaceutically acceptable salt thereof and a carbapenem antibacterial agent to achieve an in vivo Compound I plasma concentration C max from about 50 mg/L to about 200 mg/L, wherein Compound I has the structure:

and

wherein Compound I is administered in a dose range from about 15 mg/kg to about 50 mg/kg of body weight.

2. The method of claim 1 , wherein the carbapenem antibacterial agent is selected from the group consisting of Imipenem, Biapenem, Doripenem, Meropenem, and Ertapenem.

3. The method of claim 2 , wherein the carbapenem antibacterial agent is Biapenem.

4. The method of claim 1 , wherein the composition is administered intravenously.

5. The method of claim 1 , wherein the infection is caused by a bacteria selected from Pseudomonas aeruginosa, Pseudomonas aeruginosa, Pseudomonas fluorescens, Stenotrophomonas maltophilia, Escherichia coli, Citrobacter freundii, Salmonella typhimurium, Salmonella typhi, Salmonella paratyphi, Salmonella enteritidis, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Acinetobacter calcoaceticus, Acinetobacter haemolyticus, Yersinia enterocolitica, Yersinia pestis, Yersinia pseudotuberculosis, Yersinia intermedia, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus haemolyticus, Haemophilus parahaemolyticus, Helicobacter pylori, Campylobacter fetus, Campylobacter jejuni, Campylobacter coli, Vibrio cholerae, Vibrio parahaemolyticus, Legionella pneumophila, Listeria monocytogenes, Neisseria gonorrhoeae, Neisseria meningitidis, Moraxella, Bacteroides fragilis, Bacteroides vulgatus, Bacteroides ovalus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides eggerthii, and Bacteroides splanchnicus..

6. The method of claim 1 , wherein the composition further comprises an additional medicament selected from an antibacterial agent, antifungal agent, an antiviral agent, an anti-inflammatory agent, or an anti-allergic agent.

7. The method of claim 2 , wherein the carbapenem antibacterial agent is meropenem.

8. A method for treating a bacterial infection in a human, comprising administering to a subject in need thereof a composition comprising Compound I or a pharmaceutically acceptable salt thereof and a carbapenem antibacterial agent to achieve an in vivo Compound I 24 h AUC from about 45 mg*h/L to about 500 mg*h/L, wherein Compound I has the structure:

and

wherein Compound I is administered in a dose range from about 15 mg/kg to about 50 mg/kg of body weight.

9. The method of claim 8 , wherein the carbapenem antibacterial agent is selected from the group consisting of Imipenem, Biapenem, Doripenem, Meropenem, and Ertapenem.

10. The method of claim 9 , wherein the carbapenem antibacterial agent is Biapenem.

11. The method of claim 8 , wherein the composition is administered intravenously.

12. The method of claim 8 , wherein the infection is caused by a bacteria selected from Pseudomonas aeruginosa, Pseudomonas aeruginosa, Pseudomonas fluorescens, Stenotrophomonas maltophilia, Escherichia coli, Citrobacter freundii, Salmonella typhimurium, Salmonella typhi, Salmonella paratyphi, Salmonella enteritidis, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Acinetobacter calcoaceticus, Acinetobacter haemolyticus, Yersinia enterocolitica, Yersinia pestis, Yersinia pseudotuberculosis, Yersinia intermedia, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus haemolyticus, Haemophilus parahaemolyticus, Helicobacter pylori, Campylobacter fetus, Campylobacter jejuni, Campylobacter coli, Vibrio cholerae, Vibrio parahaemolyticus, Legionella pneumophila, Listeria monocytogenes, Neisseria gonorrhoeae, Neisseria meningitidis, Moraxella, Bacteroides fragilis, Bacteroides vulgatus, Bacteroides ovalus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides eggerthii, and Bacteroides splanchnicus.

13. The method of claim 8 , wherein the composition further comprises an additional medicament selected from an antibacterial agent, antifungal agent, an antiviral agent, an anti-inflammatory agent, or an anti-allergic agent.

14. The method of claim 9 , wherein the carbapenem antibacterial agent is meropenem.

Assignments (6)