Journal
JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Volume 69, Issue 7, Pages 1945-1953Publisher
OXFORD UNIV PRESS
DOI: 10.1093/jac/dku062
Keywords
non-tuberculous mycobacteria; atypical mycobacterial infections; cystic fibrosis; pulmonary
Funding
- Wyeth Research
- Cystic Fibrosis Foundation Therapeutics, Inc. [WALLAC03A]
- Pfizer Inc.
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We report the largest clinical experience using tigecycline-containing regimens for salvage treatment of patients with Mycobacterium abscessus and Mycobacterium chelonae. Data were collected from 52 patients on emergency/compassionate use (naEuroS=aEuroS38) or two open-label studies (naEuroS=aEuroS7 patients each). Based on information that was available, 46 (88.5%) of the subjects received antibiotic therapy prior to treatment with tigecycline. Treatment groups were evaluated based on length of tigecycline therapy (< 1 and a parts per thousand yen1 month). ClinicalTrials.gov identifiers: Study 205, NCT00600600 and Study 310, NCT00205816. The most commonly used concomitant antimicrobials were macrolides, amikacin and linezolid. Pulmonary disease was the most common presentation (36/52; 69.2%), and 58.3% of these patients had underlying cystic fibrosis. The majority were M. abscessus complex (naEuroS=aEuroS30) or M. chelonae/abscessus (naEuroS=aEuroS4). With therapy a parts per thousand yen1 month (mean, 255.0aEuroS +/- aEuroS265.7 days), 10/15 patients (66.7%) with cystic fibrosis and 16/26 (61.5%) overall were considered improved. Skin/soft-tissue/bone infections were the most common extrapulmonary infections. With therapy a parts per thousand yen1 month (mean, 143aEuroS +/- aEuroS123 days), 9/12 patients (75.0%) were considered improved. Nine of the 16 cases reported as failures regardless of site of infection occurred in patients who stopped treatment due to adverse events. There were eight deaths; none was related to tigecycline. Tigecycline given for a parts per thousand yen1 month as part of a multidrug regimen resulted in improvement in > 60% of patients with M. abscessus and M. chelonae infections, including those with underlying cystic fibrosis, despite failure of prior antibiotic therapy. Adverse events were reported in > 90% of cases, the most common being nausea and vomiting.
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