Study Evaluating Emergency-Use Tigecycline in Subjects With Resistant Pathogens. - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00205816

Purpose

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.

Condition	Intervention	Phase
Bacterial Infections	Drug: Tigecycline	Phase III

MedlinePlus related topics: Bacterial Infections

Drug Information available for: Tigecycline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	An Open-Label, Noncomparative, Multi-Center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.

Further study details as provided by Wyeth:

Primary Outcome Measures:

response

Secondary Outcome Measures:

micro response at subject level
micro response at pathogen level
clinical response at pathogen level
development of decreased susceptibility

Study Start Date:

September 2003

Eligibility

Ages Eligible for Study:	8 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00205816

Locations

Germany

Heidelberg, Germany, D-69120
Poland

Poznan, Poland, 60-355

Gdansk, Poland, 80-952

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3074A1-310
Study First Received:	September 16, 2005
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00205816
Health Authority:	United States: Food and Drug Administration; Germany: Ethics Commission; Poland: Ministry of Health; Canada: Health Canada

Keywords provided by Wyeth:

Bacterial Infections

Study placed in the following topic categories:

Bacterial Infections
Tigecycline
Emergencies

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Communicable Diseases
Disease Attributes

Pathologic Processes
Therapeutic Uses
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009