Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection
NCT00044928
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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)
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection | |||
Official Title ICMJE | 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 ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Primary Purpose: Treatment | |||
Condition ICMJE | Bacterial Infections | |||
Intervention ICMJE | Drug: Piperacillin/Tazobactam | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 262 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | February 2004 | |||
Actual Primary Completion Date | February 2004 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00044928 | |||
Other Study ID Numbers ICMJE | 0910X-101074 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |