A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis

This is an interventional treatment trial for Bacterial Enteritis Read More

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