title: The efficacy of fidaxomicin in the treatment of Clostridium difficile infection in a real-world clinical setting: a Spanish multi-centre retrospective cohort.
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.
authors.affiliation: Department of Infectious Diseases, Hospital Clínic de Barcelona, C/Villarroel 170, 08036, Barcelona, Spain. cfeher@clinic.ub.es.
authors.forename: C
authors.identifier: http://orcid.org/0000-0001-6679-493X
authors.initials: C
authors.lastname: Fehér
authors.affiliation: Unit of Infectious Diseases, Department of Internal Medicine, Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Múñez Rubio
authors.affiliation: Department of Microbiology, Hospital Clínico San Carlos, Madrid, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Merino Amador
authors.affiliation: Department of Microbiology, Fundación Hospital Alcorcón, Madrid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Delgado-Iribarren Garcia-Campero
authors.affiliation: Unit of Infectious Diseases, Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Salavert
authors.affiliation: Unit of Infectious Diseases, Hospital General Universitario de Alicante, Alicante, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Merino
authors.affiliation: Department of Anesthesiology and Critical Surgical Care, Hospital Universitario La Paz, Madrid, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Maseda Garrido
authors.affiliation: Unit of Infectious Diseases, Parc Sanitari Sant Joan de Deu, Sant Boi de Llobregat, Barcelona, Spain.
authors.forename: V
authors.initials: V
authors.lastname: Díaz-Brito
authors.affiliation: Department of Microbiology, Hospital Clínic de Barcelona, Barcelona, Spain.
authors.forename: M J
authors.initials: MJ
authors.lastname: Álvarez
authors.affiliation: Department of Infectious Diseases, Hospital Clínic de Barcelona, C/Villarroel 170, 08036, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Mensa
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000617:Aminoglycosides / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D016360:Clostridioides difficile / Q000187:drug effects / Q000302:isolation & purification*; D003015:Clostridium Infections / Q000188:drug therapy* / Q000382:microbiology; D003967:Diarrhea / Q000188:drug therapy* / Q000382:microbiology; D064420:Drug-Related Side Effects and Adverse Reactions; D000077732:Fidaxomicin; D006761:Hospitals; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D013030:Spain; D016019:Survival Analysis; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077732:Fidaxomicin