Intra-abdominal infections (peritonitis, intra-abdominal abscess) or hepatobiliary infections (cholecystitis, cholangitis, hepatic abscess)
Conditions
Interventions
investigational material(s)
Generic name etc : YP-18(Tazobactam/Piperacillin Hydrate)
INN of investigational material : tazobactam, piperacillin
Therapeutic category code : 613 Antibiotic preparations
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiological effect (Bacteriologic response, Pathogen response) | — |
Outcome results
None listed