title: Clinical experience in 52 patients with tigecycline-containing regimens for salvage treatment of Mycobacterium abscessus and Mycobacterium chelonae infections.
abstract: OBJECTIVE
  We report the largest clinical experience using tigecycline-containing regimens for salvage treatment of patients with Mycobacterium abscessus and Mycobacterium chelonae.
  
  
  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.
authors.affiliation: The Mycobacteria/Nocardia Research Laboratory, Department of Microbiology, The University of Texas Health Science Center at Tyler, 11937 U.S. Hwy 271, Tyler, TX 75708, USA Department of Medicine, The University of Texas Health Science Center at Tyler, 11937 U.S. Hwy 271, Tyler, TX 75708, USA richard.wallace@uthct.edu.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Wallace
authors.affiliation: Specialty Care, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA.
authors.forename: Gary
authors.initials: G
authors.lastname: Dukart
authors.affiliation: The Mycobacteria/Nocardia Research Laboratory, Department of Microbiology, The University of Texas Health Science Center at Tyler, 11937 U.S. Hwy 271, Tyler, TX 75708, USA.
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Brown-Elliott
authors.affiliation: Department of Medicine, The University of Texas Health Science Center at Tyler, 11937 U.S. Hwy 271, Tyler, TX 75708, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Griffith
authors.affiliation: Specialty Care, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA.
authors.forename: Ernesto G
authors.initials: EG
authors.lastname: Scerpella
authors.affiliation: Specialty Care, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Marshall
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000995:Antitubercular Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002648:Child; D004359:Drug Therapy, Combination / Q000379:methods; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D009165:Mycobacterium Infections, Nontuberculous / Q000188:drug therapy* / Q000382:microbiology; D009325:Nausea / Q000139:chemically induced / Q000453:epidemiology; D009170:Nontuberculous Mycobacteria / Q000302:isolation & purification*; D016879:Salvage Therapy / Q000009:adverse effects / Q000379:methods*; D000078304:Tigecycline; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000995:Antitubercular Agents; D000078304:Tigecycline; D008911:Minocycline
keywords: atypical mycobacterial infections; cystic fibrosis; non-tuberculous mycobacteria; pulmonary