Mycobacterium Abscessus Lung Disease, Rapidly Growing Mycobacterial Lung Disease
Conditions
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
Interventions
DRUGTigecycline
Tigecycline dosage based on age and clinical status of patient.
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
The University of Texas Health Science Center at Tyler
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures | 6 mos | culture neg X3 ( sputum conversion) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical and Microbiological outcomes | 6 mos | clinical and radiographic improvements |
Countries
United States
Outcome results
None listed