Clinical Trial: A Clinical Trial to Assess Three Different Doses of OPS-2071 in Patients With Bacterial Enteritis
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title:
Brief Summary: To assess safety, efficacy and pharmacokinetics of multiple dosesin patients with Bacterial Enteritis caused by Clostridium difficile infection(CDI) or Enteric infection.
Detailed Summary:
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Current Primary Outcome:
- Change of the microbiological examination [ Time Frame: CDI group: screening, Day 4, Day 11 (end of treatment), Enteric infection group: screening, Day 4, Day 8 (end of treatment) ]Judged according to the assessment criteria for the bacterial strain isolated as the causative pathogen based on the data from the microbiological examination.
- Plasma concentration of OPS-2071 on Day 4 [ Time Frame: Inpatient: 1 h, 2 h, and 4 h after morning,administration , Outpatient: Once within 12 h after morning administration but before evening ]Cmax, tmax
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The recurrence rate of CDI after multiple doses of OPS-2071 [ Time Frame: Day 38 ]
- The time to resolution of diarrhea after multiple doses of OPS-2071 [ Time Frame: CDI group: Day 4, Day 11 (end of treatment), and Day 38. Enteric infection group: Day 4, Day 8 (end of treatment) ]
- The improvement of clinical symptoms after multiple doses of OPS-2071 [ Time Frame: CDI group: Day 4, Day 11 (end of treatment), and Day 38. Enteric infection group: Day 4, Day 8 (end of treatment) ]Assess the improvement of clinical symptoms, ie, daily stool count, fecal properties, bloody stool, fever, abdominal pain, nausea, and vomiting.
- The sensitivity to OPS-2071 of the causative pathogen strain isolated from patients [ Time Frame: CDI group: screening, Day 11 (end of treatment). Enteric infection group: screening, Day 8 (end of treatment) ]Determine the minimum inhibitory concentration (MIC) of OPS-2071 for the isolated/identified Clostridium difficile (C. difficile) or The strain identified as The causative pathogen of enteric infection.
Original Secondary Outcome: Same as current
Information By: Otsuka Pharmaceutical Co., Ltd.
Dates:
Date Received: June 8, 2015
Date Started: June 2015
Date Completion: March 2017
Last Updated: March 9, 2017
Last Verified: March 2017