Back to resultsTigecycline for Treatment of Rapidly Growing Mycobacteria
Primary Purpose
Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tigecycline
Sponsored by
About this trial
This is an interventional treatment trial for Mycobacterium Abscessus Lung Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of tetracycline allergy
- If a menstruating female, not pregnant and on adequate birth control
Sites / Locations
- The University of Texas Health Science Center at Tyler
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tigecycline
Arm Description
tigecycline titrated dose according to patient age and clinical status
Outcomes
Primary Outcome Measures
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
culture neg X3 ( sputum conversion)
Secondary Outcome Measures
clinical and Microbiological outcomes
clinical and radiographic improvements
Full Information
NCT ID
NCT00600600
First Posted
January 14, 2008
Last Updated
May 19, 2017
Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00600600
Brief Title
Tigecycline for Treatment of Rapidly Growing Mycobacteria
Official Title
Use of Tigecycline for Treatment of Serious Infection Due to Rapidly Growing Mycobacteria (Especially M.Abscessus)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at Tyler
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the safety, tolerance, and efficacy of Tigecycline when given daily to patients with rapidly growing mycobacterial disease (especially M.abscessus).
Detailed Description
To assess the safety and efficacy of tigecycline in the treatment of drug resistant rapidly growing mycobacterial disease especially M. abscessus
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tigecycline
Arm Type
Experimental
Arm Description
tigecycline titrated dose according to patient age and clinical status
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Other Intervention Name(s)
tygacil
Intervention Description
Tigecycline dosage based on age and clinical status of patient.
Primary Outcome Measure Information:
Title
Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
Description
culture neg X3 ( sputum conversion)
Time Frame
6 mos
Secondary Outcome Measure Information:
Title
clinical and Microbiological outcomes
Description
clinical and radiographic improvements
Time Frame
6 mos
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of tetracycline allergy
If a menstruating female, not pregnant and on adequate birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J Wallace Jr., M.D.
Organizational Affiliation
The University of Texas Health Science Center at Tyler
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75708
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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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Tigecycline for Treatment of Rapidly Growing Mycobacteria
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