{
  "abstract": "Background and Importance Clostridioides difficile infection (CDI) is a major cause of healthcare-associated diarrhoea, associated with high morbidity, mortality, and frequent recurrences. Fidaxomicin, a narrow-spectrum macrocyclic antibiotic, has shown comparable efficacy to vancomycin with lower recurrence rates and is recommended as first-line therapy for patients at high risk of recurrence. However, real-world evidence on its effectiveness and safety as initial treatment remains limited.Aim and Objectives To evaluate the effectiveness and safety of fidaxomicin as first-line treatment for Clostridioides difficile infection in real-world clinical practice.Material and Methods A retrospective descriptive study was conducted including patients treated with fidaxomicin 200 mg every 12 hours for 10 days as first-line therapy for CDI. Data were obtained from the digital medical record (Diraya). Variables collected included sex, age, recurrence risk, antibiotic use within 3 months prior to diagnosis, active proton pump inhibitor (PPI) therapy, clinical cure, recurrence or reinfection, and complications. Effectiveness was defined as clinical cure (absence of symptoms 48 hours after the end of treatment) and recurrence (within 8 weeks) or reinfection (beyond 8 weeks). Safety was assessed by recorded adverse events.Results A total of 61 patients were included (mean age 62 ± 20 years; 59% male). Regarding the main recurrence risk factors: 64% (39/61) were immunosuppressed and 44% (27/61) were older than 65 years with severe disease. 75% (46/61) had received antibiotics within 3 months before diagnosis, of which 61% (28/46) were considered high risk. At diagnosis, 56% (34/61) were on active antibiotic therapy, which was discontinued in 56% (19/34) of cases. 80% (49/61) were on PPIs at diagnosis, which were discontinued in 65% (32/49) of patients. Clinical resolution was achieved in 87% (53/61), with recurrence in 5% (3/61) and no reinfections reported. Clinical complications occurred in 20% (12/61): 18% (11/61) pseudomembranous colitis and 1% (1/61) paralytic ileus. No adverse events were reported.Conclusion and Relevance Fidaxomicin as first-line therapy showed high effectiveness and a favourable safety profile in real-world clinical practice, with high cure rates and low recurrence. These findings support its use as a preferred therapeutic option in patients with recurrence risk factors or significant comorbidities.Conflict of Interest No conflict of interest",
  "authors": [
    {
      "affiliations": [
        "Hospital Universitario Puerta Del Mar, Farmacia Hospitalaria, Cádiz, Spain"
      ],
      "name": "MDV Rivero García"
    },
    {
      "affiliations": [
        "Hospital Universitario De Ceuta, Farmacia Hospitalaria, Cádiz, Spain"
      ],
      "name": "I Sánchez Lobón"
    },
    {
      "affiliations": [
        "Hospital Universitario Puerta Del Mar, Farmacia Hospitalaria, Cádiz, Spain"
      ],
      "name": "MDLÁ Ocaña De La Rosa"
    },
    {
      "affiliations": [
        "Hospital Universitario Puerta Del Mar, Farmacia Hospitalaria, Cádiz, Spain"
      ],
      "name": "MV Manzano Martín"
    },
    {
      "affiliations": [
        "Hospital Universitario Puerta Del Mar, Farmacia Hospitalaria, Cádiz, Spain"
      ],
      "name": "ME Rodríguez Mateos"
    }
  ],
  "title": "4CPS-256 Effectiveness and safety of fidaxomicin as first-line therapy for Clostridioides difficile infection",
  "uid": "7aac25da-c843-5466-b6f3-ac04f056593d"
}