Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2007-08-31

Brief Summary

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Tigecycline's activity against resistant organisms, as well as significant coverage of both gram-positive and gram-negative bacteria, may provide a valuable therapeutic alternative in treating patients with complicated skin and/or skin structure infections.

Detailed Description

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To evaluate the safety and the efficacy of tigecycline in treating hospitalized patients with complicated skin and/or skin structure infections.

Conditions

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Skin Diseases, Infectious

Keywords

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Tigecycline cSSSI complicated skin and skin structure infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tigecycline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Hospitalized male and female patients, 18 years of age or older.
* Anticipated need for intravenous antibiotic therapy of 5 days or longer.
* Patients known or suspected to have a complicated skin and skin structure infection.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Trial Manager

Role: PRINCIPAL_INVESTIGATOR

For Taiwan, [email protected]

Locations

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Multiple Cities, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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101993

Identifier Type: -

Identifier Source: org_study_id