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

Phase 3CompletedNCT00205816

Wyeth is now a wholly owned subsidiary of Pfizer26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bacterial Infections

Interventions

TigecyclineDRUG

Eligibility

Sex: ALLMin age: 8 Years

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Heidelberg, Germany

Unnamed facility

Gdansk, Poland

Unnamed facility

Poznan, Poland

Outcomes

Primary Outcomes

response

Secondary Outcomes

micro response at subject level

micro response at pathogen level

clinical response at pathogen level

development of decreased susceptibility

Data from ClinicalTrials.gov

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