Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

• ClinicalTrials.gov Identifier: NCT00044928
• Recruitment Status: Completed
• First Posted: September 10, 2002
• Last Update Posted: February 8, 2013
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: September 6, 2002
• First Posted Date: September 10, 2002
• Last Update Posted Date: February 8, 2013
• Study Start Date: July 2002
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection
• 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
• Brief Summary: A Phase IV, multicenter study of hospitalized patients with complicated intra-abdominal infection.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Primary Purpose: Treatment
• Condition: Bacterial Infections
• Intervention: Drug: Piperacillin/Tazobactam
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2013): 262
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 2004
• Actual Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: United States

Administrative Information

• NCT Number: NCT00044928
• Other Study ID Numbers: 0910X-101074
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Medical Monitor, MD; Wyeth is now a wholly owned subsidiary of Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: February 2013