Phase III Clinical Study of YP-18 in Intra-Abdominal Infections

Phase 3

• Conditions: Intra-abdominal infections (peritonitis, intra-abdominal abscess) or hepatobiliary infections (cholecystitis, cholangitis, hepatic abscess)

• Registration Number: JPRN-jRCT2080221068
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Patients who suffer intra-abdominal infections or hepatobiliary infections clinically demonstrated by the inflammatory, abdominal or imaging findings, and who meet any of the following criteria:
1) Patients who are to undergo surgical procedure, percutaneous drainage of infectious lesion or gallbladder/bile duct (biliary) drainage, or underwent such treatment within 24 hours. Patients who suffer pelvic inflammatory disease or cholecystitis but whose treating physicians do not perform drainage at their discretion can be also selected as the subjects. (In the latter case, collection of aspiration samples is also required.)
2) Patients who suffer postoperative infections. In such cases, the gastrointestinal tract fluid or purulent discharge from the drains left during surgery should be confirmed.
3) Patients who are diagnosed with acute cholecystitis or acute cholangitis.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified