Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection
Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Infections
Intervention: Piperacillin/Tazobactam (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer Official(s) and/or principal investigator(s):
Medical Monitor, MD, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Summary
A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal
infection.
Clinical Details
Official title: Randomized, Open-label, Comparative Study of Zosyn (Pip/Tazo [12g/1.5g]) Administered by Daily 24hr Continuous Infusion vs Zosyn (Pip/Tazo) [3g/0.375g]) q6h for the Treatment of Hospitalized Patients With Complicated Intra-abdominal Infection
Study design: Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria
- Written informed consent will be obtained prior to enrollment into the study. If any
patient is unable to give consent, it may be obtained from next of-kin or a legal
representative if in accordance with local laws and regulations
- Hospitalized, ≥18 years of age
- Male or non-pregnant, non-lactating female who is post-menopausal, surgically
sterilized or is using birth control pills, contraceptive implant or injection (ex:
NORPLANT®; DEPO-PROVERA®), intra-uterine device, barrier methods with spermicide, or
abstinence. (Effective contraception should have been in place for at least two
months prior to study entry and must continue for at least 30 days after treatment
discontinuation)
Exclusion Criteria
- Patients with underlying immunodeficiency disease or patients requiring chronic
treatment with known immunosuppressant medications including >5mg/day prednisone
- Active or treated leukemia, or systemic malignancy that required treatment with
chemotherapy, immunotherapy, radiation therapy, or antineoplastic therapy within the
past year or which is anticipated to begin prior to the Test-of-Cure visit; or any
known or suspected malignancy to the abdomen
- Concurrent hemodialysis, peritoneal dialysis or patients with indwelling peritoneal
catheters or shunts, plasmapheresis or hemoperfusion
Locations and Contacts
Additional Information
Starting date: July 2002
Last updated: February 7, 2013
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