Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

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

PHASE3

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-11-30

Brief Summary

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The purpose of this study is to provide a mechanism for the emergency use of tigecycline in the appropriate clinical situations.

The secondary objective is to evaluate the safety and efficacy of tigecycline in the treatment of patients with selected serious infections where other treatment has not been successful.

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Detailed Description

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Conditions

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Bacterial Infections

Study Design

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Allocation Method

NON_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

* Male or female subjects, greater than 8 years of age and a weight of more than 35 kilograms.
* Patients with current bacterial infections who have not responded to other available appropriate antibiotic therapies.
* Patient must give informed consent.

Exclusion Criteria

* Patients with an expected survival of less than 2 weeks.
* Patients who have been designated as "Do Not Resuscitate".
* Known or suspected hypersensitivity to tigecycline, tetracyclines, or other compounds related to this class of antibacterial agents.
* Pregnant women or nursing mothers.

Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No