NCT00228410

Brief Summary

To compare the safety and the efficacy of tigecycline to vancomycin with aztreonam in treating hospitalized patients with complicated skin and/or skin structure infections.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
503

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_3

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

November 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2005

Completed
Last Updated

February 8, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

September 26, 2005

Last Update Submit

February 7, 2013

Conditions

Skin Diseases, Infectious

Keywords

Skin InfectionsSkin Disease

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint was the clinical response in the co-primary populations of the clinically evaluable (CE) and clinical modified intent-to-treat (c-mITT) subjects at the test-of-cure assessment.

Secondary Outcomes (1)

  • Safety assessments included a physical examination and daily recording of vital signs (temperature, heart rate, blood pressure).

Interventions

TigecyclineDRUG
vancomycin with aztreonamDRUG

Eligibility Criteria

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

You may qualify if:

  • Anticipated need for intravenous antibiotic therapy of 5 days or longer.
  • Patients known or suspected to have a complicated skin and skin structure infection. Complicated skin/skin structure infection includes infections either involving deeper soft tissue or requiring significant surgical intervention or a significant underlying disease state (such as diabetes mellitus, peripheral vascular disease, peripheral neuropathy, lower venous insufficiency) that complicates response to treatment.

You may not qualify if:

  • Patients with any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed.
  • Patients with severely impaired arterial blood supply and insufficiency such that the likelihood of amputation of the infected anatomical site within one month is likely.
  • Infected diabetic foot ulcers or decubitus ulcers where the infection is present for greater than one week's duration or chronically infected decubitus ulcers in patients who can not be compliant with measures necessary for chronic wound healing.
  • Necrotizing fasciitis or gangrene.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Teras J, Gardovskis J, Vaasna T, Kupcs U, Pupelis G, Dukart G, Dartois N, Jouve S, Cooper A; 305 Study Group. Overview of tigecycline efficacy and safety in the treatment of complicated skin and skin structure infections - a European perspective. J Chemother. 2008 Oct;20 Suppl 1:20-7. doi: 10.1179/joc.2008.20.Supplement-1.20.

    PMID: 19036671DERIVED

MeSH Terms

Conditions

Skin Diseases, InfectiousCellulitisSkin Diseases

Interventions

TigecyclineVancomycinAztreonam

Condition Hierarchy (Ancestors)

InfectionsSkin and Connective Tissue DiseasesSuppurationConnective Tissue DiseasesInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlycopeptidesGlycoconjugatesCarbohydratesPeptidesAmino Acids, Peptides, and ProteinsMonobactamsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2005

First Posted

September 28, 2005

Study Start

November 1, 2002

Primary Completion

December 1, 2003

Study Completion

December 1, 2003

Last Updated

February 8, 2013

Record last verified: 2013-02