NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-101101

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedIntra-abdominal infections (peritonitis, intra-abdominal abscess) or hepatobiliary infections (cholecystitis, cholangitis, hepatic abscess)
Date of first enrollment
Target sample size100
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : YP-18(Tazobactam/Piperacillin Hydrate) INN of the intervention : tazobactam, piperacillin Dosage And administration of the intervention : YP-18 is to be administered at a dose of 4.5 g per treatment, via iv drip infusion, three times a day. Control intervention name : null

Outcome(s)

Primary OutcomeEfficacy, Safety
Secondary OutcomeMicrobiological effect (Bacteriologic response, Pathogen response)

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaPatients 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.
Exclude criteria

Related Information

Contact

public contact
Name Taiho Pharmaceutical Co., Ltd. Regulatory Affairs Dept.
Address toiawase@taiho.co.jp
Telephone
E-mail
Affiliation
scientific contact
Name Taiho Pharmaceutical Co., Ltd. Clinical Development 2 Dept.
Address toiawaseCD1@taiho.co.jp
Telephone
E-mail
Affiliation