Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.
An Open-label, Noncomparative, Multi-center, Emergency Use Protocol Administering Tigecycline for the Treatment of Subjects With Infections Due to Resistant Pathogens.
1 other identifier
interventional
26
2 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2004
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedFebruary 8, 2013
February 1, 2013
1.8 years
September 16, 2005
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
response
Secondary Outcomes (4)
micro response at subject level
micro response at pathogen level
clinical response at pathogen level
development of decreased susceptibility
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Heidelberg, D-69120, Germany
Unknown Facility
Gdansk, 80-952, Poland
Unknown Facility
Poznan, 60-355, Poland
Related Publications (1)
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.
PMID: 24633206DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
January 1, 2004
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
February 8, 2013
Record last verified: 2013-02