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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


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


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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