Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections

Richard J Wallace Jr, Gary Dukart, Barbara A Brown-Elliott, David E Griffith, Ernesto G Scerpella, Bonnie Marshall, Richard J Wallace Jr, Gary Dukart, Barbara A Brown-Elliott, David E Griffith, Ernesto G Scerpella, Bonnie Marshall

Abstract

Objectives: We report the largest clinical experience using tigecycline-containing regimens for salvage treatment of patients with Mycobacterium abscessus and Mycobacterium chelonae.

Patients and methods: Data were collected from 52 patients on emergency/compassionate use (n = 38) or two open-label studies (n = 7 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 ≥1 month). ClinicalTrials.gov identifiers: Study 205, NCT00600600 and Study 310, NCT00205816.

Results: 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 (n = 30) or M. chelonae/abscessus (n = 4). With therapy ≥1 month (mean, 255.0 ± 265.7 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 ≥1 month (mean, 143 ± 123 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.

Conclusions: Tigecycline given for ≥1 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.

Keywords: atypical mycobacterial infections; cystic fibrosis; non-tuberculous mycobacteria; pulmonary.

© The Author 2014. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy.

References

    1. Bodle EE, Cunningham JA, Della-Latta P, et al. Epidemiology of nontuberculous mycobacteria in patients without HIV infection, New York City. Emerg Infect Dis. 2008;14:390–6.
    1. Griffith DE, Aksamit T, Brown-Elliott BA, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med. 2007;175:367–416.
    1. Aksamit TR. Mycobacterium avium complex pulmonary disease in patients with pre-existing lung disease. Clin Chest Med. 2002;23:643–53.
    1. Griffith DE, Girard WM, Wallace RJ., Jr. Clinical features of pulmonary disease caused by rapidly growing mycobacteria. An analysis of 154 patients. Am Rev Respir Dis. 1993;147:1271–8.
    1. Koh WJ, Kwon OJ, Kim EJ, et al. NRAMP1 gene polymorphism and susceptibility to nontuberculous mycobacterial lung diseases. Chest. 2005;128:94–101.
    1. Olivier KN NTM in CF Study Group. The natural history of nontuberculous mycobacteria in patients with cystic fibrosis. Paediatr Respir Rev. 2004;5(Suppl A):S213–6.
    1. Phillips MS, von Reyn CF. Nosocomial infections due to nontuberculous mycobacteria. Clin Infect Dis. 2001;33:1363–74.
    1. Han D, Lee KS, Koh WJ, et al. Radiographic and CT findings of nontuberculous mycobacterial pulmonary infection caused by Mycobacterium abscessus. AJR Am J Roentgenol. 2003;181:513–7.
    1. Wallace RJ, Jr, Brown-Elliott BA, Crist CJ, et al. Comparison of the in vitro activity of the glycylcycline tigecycline (formerly GAR-936) with those of tetracycline, minocycline, and doxycycline against isolates of nontuberculous mycobacteria. Antimicrob Agents Chemother. 2002;46:3164–7.
    1. Brown BA, Wallace RJ, Jr, Onyi GO, et al. Activities of four macrolides, including clarithromycin, against Mycobacterium fortuitum, Mycobacterium chelonae, and M. chelonae-like organisms. Antimicrob Agents Chemother. 1992;36:180–4.
    1. Wallace RJ, Jr, Brown BA, Onyi GO. Susceptibilities of Mycobacterium fortuitum biovar. fortuitum and the two subgroups of Mycobacterium chelonae to imipenem, cefmetazole, cefoxitin, and amoxicillin-clavulanic acid. Antimicrob Agents Chemother. 1991;35:773–5.
    1. Woods GL, Bergmann JS, Witebsky FG, et al. Multisite reproducibility of Etest for susceptibility testing of Mycobacterium abscessus, Mycobacterium chelonae, and Mycobacterium fortuitum. J Clin Microbiol. 2000;38:656–61.
    1. Swenson JM, Wallace RJ, Jr, Silcox VA, et al. Antimicrobial susceptibility of five subgroups of Mycobacterium fortuitum and Mycobacterium chelonae. Antimicrob Agents Chemother. 1985;28:807–11.
    1. Nash KA, Brown-Elliott BA, Wallace RJ., Jr. A novel gene, erm(41), confers inducible macrolide resistance to clinical isolates of Mycobacterium abscessus but is absent from Mycobacterium chelonae. Antimicrob Agents Chemother. 2009;53:1367–76.
    1. Leao SC, Tortoli E, Euzeby JP, et al. Proposal that Mycobacterium massiliense and Mycobacterium bolletii be united and reclassified as Mycobacterium abscessus subsp. bolletii comb. nov., designation of Mycobacterium abscessus subsp. abscessus subsp. nov. and emended description of Mycobacterium abscessus. Int J Syst Evol Microbiol. 2011;61:2311–3.
    1. Koh WJ, Jeon K, Lee NY, et al. Clinical significance of differentiation of Mycobacterium massiliense from Mycobacterium abscessus. Am J Respir Crit Care Med. 2011;183:405–10.
    1. Rose WE, Rybak MJ. Tigecycline: first of a new class of antimicrobial agents. Pharmacotherapy. 2006;26:1099–110.
    1. European Medicines Agency. Tygacil 50 mg Powder for Solution for Infusion (Updated 2/20/2013) (10 December 2013, date last accessed)
    1. Wyeth Pharmaceuticals Inc. TYGACIL® (Tigecycline) Prescribing Information. . (10 December 2013, date last accessed)
    1. McGovern PC, Wible M, El-Tahtawy A, et al. All-cause mortality imbalance in the tigecycline phase 3 and 4 clinical trials. Int J Antimicrob Agents. 2013;41:463–7.
    1. Clinical and Laboratory Standards Institute. Susceptibility Testing of Mycobacteria, Nocardia, and Other Aerobic Actinomycetes-Second Edition: Approved Standard M24-A2. Wayne, PA, USA: CLSI; 2011.
    1. Garcia-Agudo L, Garcia-Martos P, Jesus I, et al. [Assessment of in vitro susceptibility to antimicrobials of rapidly growing mycobacteria by E-test] Rev Med Chil. 2009;137:912–7.
    1. Babinchak T, Ellis-Grosse E, Dartois N, et al. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin Infect Dis. 2005;41(Suppl 5):S354–67.
    1. Breedt J, Teras J, Gardovskis J, et al. Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind phase 3 comparison study with vancomycin-aztreonam. Antimicrob Agents Chemother. 2005;49:4658–66.
    1. Ellis-Grosse EJ, Babinchak T, Dartois N, et al. The efficacy and safety of tigecycline in the treatment of skin and skin-structure infections: results of 2 double-blind phase 3 comparison studies with vancomycin-aztreonam. Clin Infect Dis. 2005;41(Suppl 5):S341–53.
    1. Oliva ME, Rekha A, Yellin A, et al. A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1–301-WW; Identifier: NCT00081744] BMC Infect Dis. 2005;5:88.
    1. Sacchidanand S, Penn RL, Embil JM, et al. Efficacy and safety of tigecycline monotherapy compared with vancomycin plus aztreonam in patients with complicated skin and skin structure infections: results from a phase 3, randomized, double-blind trial. Int J Infect Dis. 2005;9:251–61.
    1. Fernández-Roblas R, Martín-de-Hijas NZ, Fernández-Martínez AI, et al. In vitro activities of tigecycline and 10 other antimicrobials against nonpigmented rapidly growing mycobacteria. Antimicrob Agents Chemother. 2008;52:4184–6.
    1. Huang YC, Liu MF, Shen GH, et al. Clinical outcome of Mycobacterium abscessus infection and antimicrobial susceptibility testing. J Microbiol Immunol Infect. 2010;43:401–6.
    1. Gitti Z, Mantadakis E, Maraki S, et al. Clinical significance and antibiotic susceptibilities of nontuberculous mycobacteria from patients in Crete, Greece. Future Microbiol. 2011;6:1099–109.
    1. Zaidi S, Elidemir O, Heinle JS, et al. Mycobacterium abscessus in cystic fibrosis lung transplant recipients: report of 2 cases and risk for recurrence. Transpl Infect Dis. 2009;11:243–8.
    1. Al-Benwan K, Ahmad S, Mokaddas E, et al. Diagnosis of endocarditis caused by Mycobacterium abscessus. Ann Saudi Med. 2010;30:408–11.
    1. Garrison AP, Morris MI, Doblecki Lewis S, et al. Mycobacterium abscessus infection in solid organ transplant recipients: report of three cases and review of the literature. Transpl Infect Dis. 2009;11:541–8.
    1. Regnier S, Cambau E, Meningaud JP, et al. Clinical management of rapidly growing mycobacterial cutaneous infections in patients after mesotherapy. Clin Infect Dis. 2009;49:1358–64.
    1. Schneider P, Monsel G, Veziris N, et al. Successful treatment of nodular lymphangitis due to Mycobacterium chelonae in two immunosuppressed patients. Dermatol Online J. 2011;17:8.
    1. Huang CW, Chen JH, Hu ST, et al. Synergistic activities of tigecycline with clarithromycin or amikacin against rapidly growing mycobacteria in Taiwan. Int J Antimicrob Agents. 2013;41:218–23.
    1. Lee CH, You HL, Wang JW, et al. Prosthetic joint infection caused by Mycobacterium alvei in an elderly patient. J Clin Microbiol. 2011;49:3096–8.
    1. Prevotat A, Bonne S, Veziris N, et al. [Mycobacterium abscessus pulmonary infection treated with tigecyclin-amikacin and cefoxitin in a diabetic patient] Med Mal Infect. 2011;41:446–8.
    1. Muralidharan G, Micalizzi M, Speth J, et al. Pharmacokinetics of tigecycline after single and multiple doses in healthy subjects. Antimicrob Agents Chemother. 2005;49:220–9.

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