The efficacy of fidaxomicin in the treatment of Clostridium difficile infection in a real-world clinical setting: a Spanish multi-centre retrospective cohort

Eur J Clin Microbiol Infect Dis. 2017 Feb;36(2):295-303. doi: 10.1007/s10096-016-2802-x. Epub 2016 Oct 8.

Abstract

The objective of this study was to evaluate the efficacy and safety of fidaxomicin in the real-life clinical setting. This was a retrospective cohort of patients with Clostridium difficile infection (CDI) treated with fidaxomicin in 20 Spanish hospitals between July 2013 and July 2014. Clinical cure, 30-day recurrence, 30-day mortality, sustained cure, and factors associated with the failure to achieve sustained cure were analyzed. Of the 72 patients in the cohort 41 (56.9 %) had a fatal underlying disease. There were 44 (61.1 %) recurrent episodes and 26 cases (36.1 %) with a history of multiple recurrences. Most episodes were severe (26, 36 %) or severe-complicated (14, 19.4 %). Clinical cure rate was 90.3 %, recurrence rate was 16.7 % and three patients (4.2 %) died during the follow-up period. Sustained cure was achieved in 52 cases (72.2 %). Adverse events were reported in five cases (6.9 %). Factors associated with the lack of sustained cure were cardiovascular comorbidity (OR 11.4; 95 %CI 1.9-67.8), acute kidney failure (OR 7.4; 95 %CI 1.3-43.1), concomitant systemic antibiotic treatment (OR 6.2; 95 %CI 1.1-36.8), and C-reactive protein value at diagnosis (OR 1.2 for each 1 mg/dl increase; 95 %CI 1.03-1.3). Fidaxomicin is an effective and well tolerable treatment for severe CDI and for cases with elevated recurrence risk.

Publication types

  • Clinical Study
  • Multicenter Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Aminoglycosides / adverse effects
  • Aminoglycosides / therapeutic use*
  • Anti-Bacterial Agents / adverse effects
  • Anti-Bacterial Agents / therapeutic use*
  • Clostridioides difficile / drug effects
  • Clostridioides difficile / isolation & purification*
  • Clostridium Infections / drug therapy*
  • Clostridium Infections / microbiology
  • Diarrhea / drug therapy*
  • Diarrhea / microbiology
  • Drug-Related Side Effects and Adverse Reactions
  • Fidaxomicin
  • Hospitals
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Spain
  • Survival Analysis
  • Treatment Outcome
  • Young Adult

Substances

  • Aminoglycosides
  • Anti-Bacterial Agents
  • Fidaxomicin