A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial
 Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
Inclusion Criteria:

 -  The patient provides written, informed consent before the clinical trial is initiated

 -  The patient has distinctive symptoms and findings of bacterial enteritis

 -  The patient has bacterial enteritis with one or more of the following causative
 pathogens either proven or presumed: C. difficile, Salmonella, Campylobacter,
 pathogenic E. coli, and other bacteria estimated to cause bacterial enteritis

 -  The patient and his/her partner are willing to take contraceptive measures from
 initiation of investigational medicinal products (IMPs) to 4 weeks after
 administration of IMPs

 Exclusion Criteria:

 -  The patient has severe or progressive underlying disease or complication, making it
 difficult to ensure safety in the study or proper efficacy assessment

 -  The patient has a current diagnosis or history of convulsive disorders, such as
 convulsion and epilepsy

 -  The patient has a severe hepatic dysfunction

 -  The patient has a severe cardiac dysfunction

 -  The patient has cardiac arrhythmia or congenital or sporadic long QTc syndrome. Or the
 patient is treated with a drug reported to prolong QTc interval

 -  The patient has a moderate or severe renal dysfunction

 -  Women with confirmed or suspected pregnancy or breast-feeding women

 -  Patients judged to be ineligible by the investigator for any other reasons