Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

262

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

September 6, 2002

First Submitted That Met QC Criteria

September 9, 2002

First Posted (Estimate)

September 10, 2002

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0910X-101074

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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