- Written informed consent will be obtained prior to enrollment into the study. If any
patient is unable to give consent, it may be obtained from next of-kin or a legal
representative if in accordance with local laws and regulations
- Hospitalized, ≥18 years of age
- Male or non-pregnant, non-lactating female who is post-menopausal, surgically
sterilized or is using birth control pills, contraceptive implant or injection (ex:
NORPLANT®; DEPO-PROVERA®), intra-uterine device, barrier methods with spermicide, or
abstinence. (Effective contraception should have been in place for at least two months
prior to study entry and must continue for at least 30 days after treatment
discontinuation)
- Patients with underlying immunodeficiency disease or patients requiring chronic
treatment with known immunosuppressant medications including >5mg/day prednisone
- Active or treated leukemia, or systemic malignancy that required treatment with
chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the
past year or which is anticipated to begin prior to the Test-of-Cure visit; or any
known or suspected malignancy to the abdomen
- Concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal
catheters or shunts, plasmapheresis or hemoperfusion