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

Bacterial Infections Clinical Trial

Official title:

An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205816
• Other study ID #: 3074A1-310
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2005
• Last updated: February 7, 2013
• Start date: January 2004
• Est. completion date: November 2005

Study information

• Verified date: February 2013
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Ethics CommissionPoland: Ministry of HealthCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Infections
• Infection

Intervention

Drug:
• Tigecycline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response
Secondary	micro response at subject level
Secondary	micro response at pathogen level
Secondary	clinical response at pathogen level
Secondary	development of decreased susceptibility