Fidaxomicin for treatment of Clostridium difficile infection in clinical practice: a prospective cohort study in a French University Hospital
- 715 Downloads
Two randomized controlled trials (RCTs) showed the non-inferiority of fidaxomicin compared with vancomycin for Clostridium difficile infection (CDI) treatment and its superiority regarding recurrence rate. The aim of this study was to evaluate fidaxomicin’s efficacy in clinical practice.
This single-center prospective cohort study included hospitalized patients treated with fidaxomicin for CDI. Demographic, clinical and biological data were collected. Primary outcome was efficacy of fidaxomicin (clinical cure, recurrence and global cure) at 10 weeks. Secondary outcome was efficacy among different subgroups.
Ninety-nine patients were included: 42 severe CDI, 16 complicated CDI and 41 recurrent CDI. Rates of clinical cure, recurrence and global cure were 87, 15 and 59%, respectively. Subgroup analysis showed a higher recurrence rate for patients with recurrent CDI compared with first episode (8 vs. 26%; p = 0.04). Binary toxin was associated with severe/complicated CDI (80 vs. 50%; p < 0.01) and recurrence (32 vs. 7%; p < 0.01). Fidaxomicin was used as a first line for 83% of the patients with recurrence and for only 52% of first episodes even though 86% had recurrence’s risk factors.
Compared with RCTs, fidaxomicin in real world is used for patients with more severe and recurrent CDI, but clinical cure and recurrence rates were similar. Comparative studies are needed in these specific subgroups. Our data also illustrate clinicians’ difficulty to define a “patient at risk for recurrence” among the first episodes. Finally, we showed that binary toxin could be important in the screening for severity and recurrence risks.
KeywordsFidaxomicin Clostridium difficile Prospective Clinical practice
Compliance with ethical standards
Conflict of interest
The authors decline conflicts of interest regarding this work and did not receive external funding.
- 4.Davies KA, Longshaw CM, Davis GL, et al. Underdiagnosis of Clostridium difficile across Europe: the European, multicentre, prospective, biannual, point-prevalence study of Clostridium difficile infection in hospitalised patients with diarrhoea (EUCLID). Lancet Infect Dis. 2014;14:1208–19.CrossRefPubMedGoogle Scholar
- 6.Hensgens MPM, Dekkers OM, Goorhuis A, LeCessie S, Kuijper EJ. Predicting a complicated course of Clostridium difficile infection at the bedside. Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis. 2014;20:O301–8.Google Scholar
- 8.Le Monnier A, Duburcq A, Zahar J-R, et al. Hospital cost of Clostridium difficile infection including the contribution of recurrences in French acute-care hospitals. Infect: J Hosp; 2015.Google Scholar
- 9.Olsen MA, Yan Y, Reske KA, Zilberberg MD, Dubberke ER. Recurrent Clostridium difficile infection is associated with increased mortality. Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis. 2015;21:164–70.Google Scholar
- 17.Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis. 2012;18:21–7.Google Scholar
- 24.Debast SB, Bauer MP, Kuijper EJ. Committee. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect Off Publ Eur Soc Clin Microbiol Infect Dis. 2014;20:1–26.Google Scholar
- 29.Fehér C, Múñez Rubio E, Merino Amador P, et al. 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. 2016. [Epub ahead of print].Google Scholar
- 30.Goldenberg SD, Brown S, Edwards L, et al. The impact of the introduction of fidaxomicin on the management of Clostridium difficile infection in seven NHS secondary care hospitals in England: a series of local service evaluations. Eur J Clin Microbiol Infect Dis Off Publ Eur Soc Clin Microbiol. 2016;35:251–9.CrossRefGoogle Scholar
- 35.Sailhamer EA, Carson K, Chang Y, et al. Fulminant Clostridium difficile colitis: patterns of care and predictors of mortality. Arch Surg. 2009;144:433–9 (discussion 439–440).Google Scholar
- 45.Rubio-Terrés C, Cobo Reinoso J, Grau Cerrato S, et al. Economic assessment of fidaxomicin for the treatment of Clostridium difficile infection (CDI) in special populations (patients with cancer, concomitant antibiotic treatment or renal impairment) in Spain. Eur J Clin Microbiol Infect Dis Off Publ Eur Soc Clin Microbiol. 2015;34:2213–23.CrossRefGoogle Scholar