Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections

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ClinicalTrials.gov Identifier: NCT00228410

Recruitment Status : Completed

First Posted : September 28, 2005

Last Update Posted : February 8, 2013

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Wyeth is now a wholly owned subsidiary of Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Skin Diseases, Infectious	Drug: Tigecycline Drug: vancomycin with aztreonam	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	503 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	A Multicenter, Randomized, Double-Blind Comparison of the Safety and Efficacy of Tigecycline With Those of Vancomycin With Aztreonam to Treat Complicated Skin and Skin Structure Infections in Hospitalized Patients.
Study Start Date :	November 2002
Actual Primary Completion Date :	December 2003
Actual Study Completion Date :	December 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions Skin Infections

Drug Information available for: Vancomycin Vancomycin hydrochloride Aztreonam Tigecycline

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Other inclusion applies

Exclusion Criteria:

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.

Other exclusion applies.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00228410

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

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Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00228410
Other Study ID Numbers:	3074A1-305
First Posted:	September 28, 2005 Key Record Dates
Last Update Posted:	February 8, 2013
Last Verified:	February 2013

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:


Skin Infections Skin Disease

Additional relevant MeSH terms:

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Infections Communicable Diseases Skin Diseases, Infectious Skin Diseases Disease Attributes Pathologic Processes Vancomycin	Tigecycline Aztreonam Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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