NCT00044928

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
262

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2002

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2002

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2002

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.6 years

First QC Date

September 6, 2002

Last Update Submit

February 7, 2013

Conditions

Bacterial Infections

Keywords

Abdominal Infections

Interventions

Piperacillin/TazobactamDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bacterial InfectionsIntraabdominal Infections

Interventions

Piperacillin, Tazobactam Drug Combination

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TazobactamPenicillanic AcidPenicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsPiperacillinAmpicillinPenicillin GSulfur CompoundsSulfonesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2002

First Posted

September 10, 2002

Study Start

July 1, 2002

Primary Completion

February 1, 2004

Study Completion

February 1, 2004

Last Updated

February 8, 2013

Record last verified: 2013-02