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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00205816
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:

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 or disease Intervention/treatment Phase
Bacterial Infections Drug: Tigecycline Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
Study Start Date : January 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Tigecycline
U.S. FDA Resources

Primary Outcome Measures :
  1. response

Secondary Outcome Measures :
  1. micro response at subject level
  2. micro response at pathogen level
  3. clinical response at pathogen level
  4. development of decreased susceptibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00205816

Heidelberg, Germany, D-69120
Gdansk, Poland, 80-952
Poznan, Poland, 60-355
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00205816     History of Changes
Other Study ID Numbers: 3074A1-310
First Posted: September 20, 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:
Bacterial Infections

Additional relevant MeSH terms:
Bacterial Infections
Disease Attributes
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents