Efficacy of tigecycline for the treatment of complicated skin and soft-tissue infections in real-life clinical practice from five European observational studies

J Antimicrob Chemother. 2013 Jul;68 Suppl 2:ii15-24. doi: 10.1093/jac/dkt141.

Abstract

Objectives: Tigecycline is an approved treatment for complicated skin and soft-tissue infections (cSSTIs). The efficacy of tigecycline as monotherapy or in combination with other antibacterials in the treatment of cSSTI in routine practice is described.

Patients and methods: Individual patient-level data were pooled from five European observational studies (July 2006 to October 2011).

Results: A total of 254 cSSTI patients who received tigecycline were included (mean age 63.2 ± 14.9 years). Of these, 34.4% were in intensive care units, 54.5% acquired their infection in hospital and 90.9% had at least one comorbidity. Infection most commonly affected the limbs (62.4%) and 43.8% of infections were classified as necrotizing. The mean Acute Physiology and Chronic Health Evaluation (APACHE) II and Sequential Organ Failure Assessment (SOFA) scores at the beginning of treatment were 15.0 ± 7.9 (n = 205) and 5.8 ± 3.9 (n = 32), respectively, indicating high disease severity. Staphylococcus aureus (52.7%), Escherichia coli (18.0%) and Enterococcus faecium (12.0%) were the most frequently isolated pathogens; 32.9% of infections were polymicrobial and 30.5% were due to resistant pathogens. Overall, 71.8% received tigecycline as monotherapy and 28.2% as combination therapy for a mean duration of 12 days. Clinical response rates at the end of treatment were 79.6% for all patients who received the standard dosage (183/230), 86.7% for patients who received tigecycline as monotherapy (143/165), 75.0% for patients with a nosocomial infection (96/128), 75.3% for patients with an APACHE II score >15 (61/81) and 58.3% for patients with a SOFA score ≥ 7 (7/12).

Conclusions: In these real-life studies, tigecycline, alone and in combination, achieved favourable clinical response rates in patients with cSSTI with a high severity of illness.

Trial registration: ClinicalTrials.gov NCT00488488 NCT00799591 NCT00827541.

Keywords: broad-spectrum antibacterial therapy; glycylcycline antibiotics; necrotizing skin infections; non-interventional studies.

Publication types

  • Meta-Analysis
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents / therapeutic use*
  • Drug Therapy, Combination / methods
  • Europe
  • Female
  • Gram-Negative Bacterial Infections / drug therapy*
  • Gram-Positive Bacterial Infections / drug therapy*
  • Humans
  • Male
  • Middle Aged
  • Minocycline / analogs & derivatives*
  • Minocycline / therapeutic use
  • Skin Diseases, Bacterial / drug therapy*
  • Soft Tissue Infections / drug therapy*
  • Tigecycline
  • Treatment Outcome
  • Young Adult

Substances

  • Anti-Bacterial Agents
  • Tigecycline
  • Minocycline

Associated data

  • ClinicalTrials.gov/NCT00488488
  • ClinicalTrials.gov/NCT00799591
  • ClinicalTrials.gov/NCT00827541