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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00205816
First received: September 16, 2005
Last updated: February 7, 2013
Last verified: February 2013
  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 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Enrollment: 26
Study Start Date: January 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00205816     History of Changes
Other Study ID Numbers: 3074A1-310
Study First Received: September 16, 2005
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
Germany: Ethics Commission
Poland: Ministry of Health
Canada: Health Canada

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Bacterial Infections

Additional relevant MeSH terms:
Bacterial Infections
Emergencies
Disease Attributes
Pathologic Processes
Tigecycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014