Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00044928
First received: September 6, 2002
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Bacterial Infections
Drug: Piperacillin/Tazobactam
Phase 4

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:


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

Enrollment: 262
Study Start Date: July 2002
Study Completion Date: February 2004
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00044928     History of Changes
Other Study ID Numbers: 0910X-101074
Study First Received: September 6, 2002
Last Updated: February 7, 2013
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 April 15, 2014