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

Primary Purpose

Bacterial Infections

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tigecycline
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bacterial Infections focused on measuring Bacterial Infections

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Outcomes

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

Full Information

First Posted
September 16, 2005
Last Updated
February 7, 2013
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00205816
Brief Title
Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
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 Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infections
Keywords
Bacterial Infections

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tigecycline
Primary Outcome Measure Information:
Title
response
Secondary Outcome Measure Information:
Title
micro response at subject level
Title
micro response at pathogen level
Title
clinical response at pathogen level
Title
development of decreased susceptibility

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Wyeth is now a wholly owned subsidiary of Pfizer
Official's Role
Study Director
Facility Information:
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
City
Poznan
ZIP/Postal Code
60-355
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24633206
Citation
Wallace RJ Jr, Dukart G, Brown-Elliott BA, Griffith DE, Scerpella EG, Marshall B. Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections. J Antimicrob Chemother. 2014 Jul;69(7):1945-53. doi: 10.1093/jac/dku062. Epub 2014 Mar 14.
Results Reference
derived

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

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