NCT00079989

Brief Summary

To evaluate the safety and efficacy of tigecycline in the treatment of subjects with selected serious infections caused by resistant gram-negative bacteria, eg, Acinetobacter baumannii, Enterobacter species, Klebsiella pneumoniae or other resistant gram-negative pathogens, for whom antibiotics have failed or who cannot tolerate other appropriate antimicrobial therapies. The primary efficacy endpoint will be the clinical response.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2003

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2004

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.9 years

First QC Date

March 19, 2004

Last Update Submit

February 7, 2013

Conditions

Gram-Negative Bacterial Infections

Keywords

Bacterial Infections

Interventions

tigecyclineDRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female subjects aged 18 years or older
  • Isolation of a resistant gram-negative pathogen, eg, Enterobacter species, Acinetobacter baumannii, Klebsiella pneumoniae, or other resistant gram-negative pathogens, alone or as 1 isolate of a polymicrobial infection
  • Resistant gram-negative organisms are defined by the likely presence of ESBL or related mechanisms which limit the therapeutic alternatives for the treatment of complicated infections

You may not qualify if:

  • Subjects with any concomitant condition or taking any concomitant medication that, in the opinion of the investigator, could preclude an evaluation of a response or make it unlikely that the contemplated course of therapy or follow-up assessment will be completed or that will substantially increase the risk associated with the subject's participation in this study
  • Anticipated length of antibiotic therapy \< 7 days
  • Known or suspected hypersensitivity to tigecycline or other compounds related to this class of antibacterial agents (eg, tetracyclines, minocycline, doxycycline)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gram-Negative Bacterial InfectionsBacterial Infections

Interventions

Tigecycline

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Medical Monitor, MD

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2004

First Posted

March 23, 2004

Study Start

December 1, 2003

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

February 8, 2013

Record last verified: 2013-02