ORIGINAL ARTICLE The efficacy of fidaxomicin in the treatment of Clostridium difficile infection in a real-world clinical setting: a Spanish multi-centre retrospective cohort C. Fehér 1 & E. Múñez Rubio 2 & P. Merino Amador 3 & A. Delgado-Iribarren Garcia-Campero 4 & M. Salavert 5 & E. Merino 6 & E. Maseda Garrido 7 & V. Díaz-Brito 8 & M. J. Álvarez 9 & J. Mensa 1 Received: 28 July 2016 /Accepted: 23 September 2016 # Springer-Verlag Berlin Heidelberg 2016 Abstract The objective of this study was to evaluate the ef- ficacy 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 %) recur- rent 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 %, re- currence 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), con- comitant 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. Introduction Fidaxomicin, a novel macrocyclic antibiotic, is the latest in- corporation in the group of antibiotics used against Clostridium difficile infection (CDI). It exerts a blocking ef- fect on several bacterial RNA polymerases impeding tran- scription initiation and thus inhibits bacterial proliferation. It was first approved in 2011 in Europe and in 2012 in Spain but did not become widely utilized until 2014, after the publication of the latest ESCMID guidelines [1], which recommend its use for both non-severe and severe CDI, and especially in the treatment of recurrent CDI, given the in- creased risk of further recurrences in this last group of patients. Under controlled circumstances fidaxomicin demonstrated to be comparable to vancomycin in the treatment of mild to severe-uncomplicated Clostridium difficile infection (CDI) in terms of clinical cure [2–4], and superior to this in terms of recurrence rates [4, 5]. The fact that fidaxomicin largely spares intestinal microbiota owing to its narrow antibiotic spectrum [6, 7] and its inhibitory effect on bacterial sporulation [8] are probably the keys to its capacity of reducing CDI recurrence * C. Fehér cfeher@clinic.ub.es 1 Department of Infectious Diseases, Hospital Clínic de Barcelona, C/ Villarroel 170, 08036 Barcelona, Spain 2 Unit of Infectious Diseases, Department of Internal Medicine, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain 3 Department of Microbiology, Hospital Clínico San Carlos, Madrid, Spain 4 Department of Microbiology, Fundación Hospital Alcorcón, Madrid, Spain 5 Unit of Infectious Diseases, Hospital Universitario y Politécnico La Fe, Valencia, Spain 6 Unit of Infectious Diseases, Hospital General Universitario de Alicante, Alicante, Spain 7 Department of Anesthesiology and Critical Surgical Care, Hospital Universitario La Paz, Madrid, Spain 8 Unit of Infectious Diseases, Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Barcelona, Spain 9 Department of Microbiology, Hospital Clínic de Barcelona, Barcelona, Spain Eur J Clin Microbiol Infect Dis DOI 10.1007/s10096-016-2802-x