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Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00044928
Recruitment Status : Completed
First Posted : September 10, 2002
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

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

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: Piperacillin/Tazobactam Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 262 participants
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
Study Start Date : July 2002
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00044928

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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Study Director: Medical Monitor, MD Wyeth is now a wholly owned subsidiary of Pfizer
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Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00044928    
Other Study ID Numbers: 0910X-101074
First Posted: September 10, 2002    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 2013
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Abdominal Infections
Additional relevant MeSH terms:
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Communicable Diseases
Bacterial Infections
Intraabdominal Infections
Piperacillin, Tazobactam Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action