Study Evaluating Zosyn in Hospitalized Patients With Intra-Abdominal Infection

This study has been completed.

First Received on September 6, 2002. Last Updated on October 9, 2007 History of Changes

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00044928

Purpose

A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection.

Condition	Intervention	Phase
Bacterial Infections	Drug: Piperacillin/Tazobactam	Phase IV

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Piperacillin sodium Piperacillin Tazobactam Zosyn

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00044928

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor, MD

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00044928 History of Changes
Other Study ID Numbers:	0910X-101074
Study First Received:	September 6, 2002
Last Updated:	October 9, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Abdominal Infections

Additional relevant MeSH terms:

Bacterial Infections
Piperacillin
Piperacillin-tazobactam combination product
Penicillanic Acid
Tazobactam
Anti-Bacterial Agents

Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012