Treatment of Clostridium Difficile Infection in High Risk Patients

1 . A method of preventing in a subject at high risk of developing a Clostridium difficile infection, or treating a Clostridium difficile infection (CDI) in a subject in need thereof, comprising administering to the subject an effective amount of a compound of Formula I:

or a pharmaceutically acceptable salt, hydrate or solvate thereof.

2 . The method of claim 1 wherein the subject is immuno-compromised.

3 . The method of claim 1 wherein the subject has received an organ or tissue transplant, chemotherapy or immunosuppressant treatment.

4 . The method of claim 3 wherein the tissue transplant is a bone marrow transplant.

5 . The method of claim 3 wherein the tissue transplant is a hemotopoietic stem cell transplant.

6 . The method of claim 1 wherein the subject is suffering from Acute Lymphoblastic Leukemia (ALL) or Acute Myeloid Leukemia (AML).

7 . The method of claim 1 wherein the subject is also is suffering from a different bacterial infection selected from pneumonia, pulmonary infection, antibiotic-resistant infection, septicemia, wound infection, a skin infection and a soft tissue infection.

8 . The method of claim 1 wherein the subject has received a dialysis procedure.

9 . The method of claim 1 wherein the subject is suffering from urinary incontinence or diarrhea.

10 . The method of claim 9 wherein the incontinence is urinary incontinence or bowel incontinence.

11 . The method of claim 7 wherein the bacteria is in a wound.

12 . The method of claim 1 wherein the subject is receiving prophylactic treatment.

13 . The method of claim 12 wherein the prophylactic treatment is selected from antibacterial, antifungal or antiviral agents.

14 . The method of claim 1 wherein the subject is receiving treatment in an intensive care unit.

15 . The method of claim 7 wherein the bacteria is an antibiotic resistant bacteria.

16 . The method of claim 7 wherein the bacteria is a gram-positive bacteria.

17 . The method of claim 7 wherein the bacteria is a gram-negative bacteria.

18 . The method of claim 7 wherein the bacteria is selected from Streptococcus spp., Staphylococcus spp., methicillin-resistant Staphylococcus, Enterococcus spp., Haemophilus spp., Moraxella catarrhalis, Peptostreptococcus spp., Clostridium diptheriae, Actinobacillus haemolyticum; Mycoplasma pneumoniae, Legionella pneumophila, Corynebacterium minutissimum, Bartonella henselae, Treponema pallidum, Ureaplasma urealyticum, Neiserria gonorrhea, Helicobacter pylori, Borrelia recurrentis, Borrelia burgdorferi, Listeria spp.; Mycobacterium spp., Campylobacter jejuni, Cryptosporidium spp.; Bordetella pertussis, Bacteroides spp., E. coli, Serpulina hyodyisinteriae, Fusobacterium spp., Alcaligenes spp., Eubacterium spp., Peptostreptococcus spp., Porphyromonas spp. and Prevotella spp and combinations thereof.

19 . The method of claim 7 , wherein the pneumonia is selected from the group consisting of community acquired pneumonia (CAP), ventilator associated pneumonia (VAP), hospital acquired pneumonia (HAP), and healthcare associated pneumonia (HCAP).

20 . The method of claim 7 wherein the antibiotic-resistant infection is caused by Methicillin-resistant Staphylococcus aureus (MRSA) or Enterococcus.

21 . The method of claim 20 , wherein the Enterococcus is vancomycin-resistant enterococci (VRE).

22 . The method of claim 1 wherein the compound of Formula I is administered as a pharmaceutical composition.

23 . The method of claim 22 wherein the pharmaceutical composition of Formula I is administered orally.

24 . The method of claim 23 wherein the active pharmaceutical ingredient of the pharmaceutical formulation contains at least 93% by weight of total active ingredient of the compound of Formula I.

25 . The method of claim 1 wherein the subject is receiving concurrent antibiotic therapy.

26 . The method of claim 1 wherein the subject is a human.