Tigecycline for Treatment of Rapidly Growing Mycobacteria
Phase 2
Completed
- Conditions
- Rapidly Growing Mycobacterial Lung DiseaseMycobacterium Abscessus Lung Disease
- Interventions
- Registration Number
- NCT00600600
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tigecycline Tigecycline tigecycline titrated dose according to patient age and clinical status
- Primary Outcome Measures
Name Time Method Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures 6 mos culture neg X3 ( sputum conversion)
- Secondary Outcome Measures
Name Time Method clinical and Microbiological outcomes 6 mos clinical and radiographic improvements
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Tyler
🇺🇸Tyler, Texas, United States