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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series, 5 patients (one man and four women) aged 34−64 years were described, who developed recurrent Clostridium difficile infections (rCDI) during treatment with azathioprine, azithromycin, cefalexin, ceftriaxone, ciclosporin, cotrimoxazole, doxycycline, fidaxomicin, levofloxacin, mycophenolate mofetil, prednisone, tacrolimus or valganciclovir [not all routes, dosages, indications and durations of treatments to reactions onsets stated].
Patient 1: A 64-year-old woman, who had history of polycystic kidney disease complicated by renal failure, required a living unrelated donor kidney transplant in 2002. In 2010, 8 years after her kidney transplant, she developed first episode of CDI, following treatment of cefalexin [cephalexin] for cellulitis. Thereafter, she developed...
- Lin SC, et al. Fecal microbiota transplantation for recurrent Clostridium difficile infection in patients with solid organ transplants: an institutional experience and review of the literature. Transplant Infectious Disease 20: e12967, No. 6, Dec 2018. Available from: URL: http://doi.org/10.1111/tid.12967 - USA