METHODS FOR TREATING AND PREVENTING C. DIFFICILE INFECTION
Methods of treating or preventing a C. difficile infection and the associated pathological conditions related to C. difficile infection, are disclosed.
1 . A method of treating C. difficile infection in a subject in need thereof, the method comprising administering to said subject an effective amount of a compound, or a salt thereof, wherein the compound is compound A′ having the following structural formula:
such that said C. difficile infection in said subject is treated.
2 . The method of claim 1 , wherein said C. difficile infection is a recurrent C. difficile infection.
3 . The method of claim 1 , wherein said compound is administered in combination with at least one or more additional therapy used for treating C. difficile infection.
4 . The method of claim 3 , wherein said additional therapy comprises administering an antibiotic.
5 . The method of claim 4 , wherein said antibiotic is metronidazole or vancomycin.
6 . The method of claim 3 , wherein said additional therapy comprises administering a probiotic.
7 . The method of claim 3 , wherein said additional therapy comprises administering a fecal transplant.
8 . A method of treating a bacterial infection without causing C. difficile infection in a subject who is at risk of developing a C. difficile infection, said method comprising administering to said subject an effective amount of a compound, or a salt thereof, wherein said compound is compound A′ having the following structural formula:
such that said bacterial infection in said subject is treated without causing C. difficile infection.
9 . A method of treating a bacterial infection without substantially disrupting gut microbiome in a subject who is at risk of developing a C. difficile infection, said method comprising administering to said subject an effective amount of a compound, or a salt thereof, wherein said compound is compound A′ having the following structural formula:
such that said bacterial infection in said subject is treated without substantially disrupting gut microbiome.
10 . The method of claim 9 , wherein treating bacterial infection without substantially disrupting gut microbiome does not result in a C. difficile infection in said subject.
11 . The method of any one of claims 1-10 , further comprising, prior to administering, selecting a subject at risk of developing a C. difficile infection.
12 . A method of treating a bacterial infection in a subject who is predisposed to developing a C. difficile infection, said method comprising administering to said subject an effective amount of a compound, or a salt thereof, wherein said compound is compound A′ having the following structural formula:
such that said bacterial infection in said subject is treated.
13 . A method of treating a bacterial infection in a subject who is at risk of developing C. difficile infection, said method comprising the steps of:
selecting a subject at risk of developing a C. difficile infection; and
administering to said subject an effective amount of a compound, wherein the compound is compound A′, or a salt thereof, having the following structural formula:
such that said bacterial infection in said subject is treated.
14 . The method of any one of claims 8-13 , wherein said bacterial infection is selected from the group consisting of skin or skin structure infection, community-acquired bacterial pneumonia (CABP) and urinary tract infection (UTI).
15 . The method of any one of claims 8-13 , wherein said bacterial infection is caused by a gram positive bacterium.
16 . The method of any one of claims 8-13 , wherein said bacterial infection is caused by a gram negative bacterium.
17 . The method of any one of claims 8-14 , wherein said bacterial infection is caused by a bacterium belonging to the species selected from the group consisting of: E. coli, S. aureus, E. faecalis, K. pneumoniae, E. hirae, A. baumanii, B. catarrhalis, H. influenza, P. aeruginosa, and E. faecium.
18 . The method of claim 17 , wherein said S. aureus is methicillin-resistant S. aureus (MRSA) or methicillin-susceptible S. aureus (MSSA).
19 . The method of any one of claims 8-14 , wherein said bacterial infection is caused by a bacterium belonging to the genus selected from the group consisting of: Salmonella and Streptococcus.
20 . The method of any one of claims 1-19 , wherein said compound is Compound A having the following structural formula:
21 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who was recently treated with one or more antibiotic.
22 . The method of claim 21 , wherein said antibiotic was a broad spectrum antibiotic.
23 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who has had surgery of the gastrointestinal tract.
24 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who has a disease of the colon.
25 . The method of claim 24 , wherein said disease of the colon is an inflammatory bowel disease or colorectal cancer.
26 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who has a weakened immune system.
27 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who is on chemotherapy.
28 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who previously had a C. difficile infection.
29 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who is 65 years or older.
30 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who has a kidney disease.
31 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who takes proton-pump inhibitors.
32 . The method of any one of claims 1-20 , wherein the subject at risk of developing C. difficile infection is a subject who is living in an environment that predisposes said subject to developing a C. difficile infection.
33 . The method of claim 26 , wherein said environment comprises a hospital.
34 . The method of claim 26 , wherein said environment comprises a nursing home.
35 . The method of claim 26 , wherein said environment comprises an assisted living facility.
36 . The method of any one of claims 1-35 , wherein said compound is administered orally.
37 . The method of any one of claims 1-35 , wherein said compound is administered intravenously.
38 . The method of any one of claims 1-35 , wherein said compound is administered as at least one intravenous dose, followed by at least one oral dose.
39 . The method of claim 38 , wherein said at least one oral dose is administered about 24 hours after said at least one intravenous dose.
40 . The method of any one of claims 1-39 , wherein said compound is administered once per day or twice per day.
41 . The method of any one of claims 1-40 , wherein said compound is administered at the dose of about 100 mg, about 200 mg, about 300 mg, about 600 mg or about 900 mg.
42 . The method of any one of claims 1-40 , wherein said subject is treated up to and including about 14 days, up to and including about 10 days, up to and including about 9 days, up to and including about 8 days, or up to and including about 7 days.
43 . The method of any one of claims 1, 8, 9, 12 or 13 , wherein said salt is a hydrochloride salt.
44 . The method of any one of claims 1, 8, 9, 12 or 13 , wherein said salt is a tosylate salt.