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

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, D-69120
  • Poland
      • Gdansk, Poland, 80-952
      • Poznan, Poland, 60-355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
response

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

November 1, 2005

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

February 8, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3074A1-310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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