Tigecycline for Treatment of Rapidly Growing Mycobacteria
Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
1 other identifier
interventional
8
1 country
1
Brief Summary
To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2002
Longer than P75 for phase_2
1 active site
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
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
January 14, 2008
CompletedFirst Posted
Study publicly available on registry
January 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedMay 23, 2017
May 1, 2017
8 years
January 14, 2008
May 19, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
culture neg X3 ( sputum conversion)
6 mos
Secondary Outcomes (1)
clinical and Microbiological outcomes
6 mos
Study Arms (1)
Tigecycline
EXPERIMENTALtigecycline titrated dose according to patient age and clinical status
Interventions
Tigecycline dosage based on age and clinical status of patient.
Eligibility Criteria
You may qualify if:
- Positive cultures for rapidly growing mycobacteria
- Patients who have drug resistant isolates or are intolerant of macrolides or have serious infections unresponsive to currently available drugs
- Adults and children 10 years of age and older
- Pretreatment isolate of M. avium complex available for MIC determination
- Available for followup appointments
You may not qualify if:
- History of tetracycline allergy
- If a menstruating female, not pregnant and on adequate birth control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Tyler
Tyler, Texas, 75708, United States
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
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J Wallace Jr., M.D.
The University of Texas Health Science Center at Tyler
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chairman Department of Microbiology
Study Record Dates
First Submitted
January 14, 2008
First Posted
January 25, 2008
Study Start
April 1, 2002
Primary Completion
April 1, 2010
Study Completion
December 1, 2010
Last Updated
May 23, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share