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Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

Last updated on December 12, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bacterial Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00044928
Pfizer
Completed
Study Evaluating Zosyn in Hospitalized Patients With Intra-abdominal Infection

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Descriptive Information
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
 (submitted: February 7, 2013)
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

  • 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  ICMJE
Sexes Eligible for Study: All
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
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

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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