2019
DOI: 10.1093/cid/ciz1149
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Abstract: Background Fidaxomicin, a narrow-spectrum antibiotic approved for Clostridioides (Clostridium) difficile infection (CDI) in adults, is associated with lower rates of recurrence than vancomycin; however, pediatric data are limited. This multicenter, investigator-blind, phase 3, parallel-group trial assessed the safety and efficacy of fidaxomicin in children. Methods Patients aged <18 years with confirmed CDI were random… Show more

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Cited by 50 publications
(45 citation statements)
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“…It demonstrated safety, as the rate of adverse events was similar, and indeed fewer in the fidaxomicin group. It demonstrated efficacy, with similar rates of resolution of diarrhea in the fidaxomicin vs vancomycin group (75.5% vs 72.7%), shorter time to resolution in fidaxomicin group (58 h vs 97 h), and fewer rates of recurrence (11.8% vs 29%) [ 35 •]. This study shows that in pediatrics, fidaxomicin is associated with a higher rate of clinical response without recurrence.…”
Section: New Developments In Treatment Options and Future Directionsmentioning
confidence: 76%
See 1 more Smart Citation
“…It demonstrated safety, as the rate of adverse events was similar, and indeed fewer in the fidaxomicin group. It demonstrated efficacy, with similar rates of resolution of diarrhea in the fidaxomicin vs vancomycin group (75.5% vs 72.7%), shorter time to resolution in fidaxomicin group (58 h vs 97 h), and fewer rates of recurrence (11.8% vs 29%) [ 35 •]. This study shows that in pediatrics, fidaxomicin is associated with a higher rate of clinical response without recurrence.…”
Section: New Developments In Treatment Options and Future Directionsmentioning
confidence: 76%
“…Pediatric patients with comorbidities such as inflammatory bowel disease, immunosuppressed condition, or with abdominal surgical procedures (i.e., g-tubes, colostomy) face a significant risk of recurrence after the initial episode; however, currently fidaxomicin is only used off-label. The SUNSHINE study, a multicenter, investigator-blind, phase 3 trial study, supports the use of fidaxomicin in pediatrics as a non-inferior and safe option to vancomycin [ 35 •]. The patients in this study had one or more comorbidities.…”
Section: New Developments In Treatment Options and Future Directionsmentioning
confidence: 88%
“…While the number of patients who reached a confirmed clinical response at 2 days after the end of treatment was 77.6% (76/98) in the fidaxomicin arm and 70.5% (31/44) in the vancomycin arm, CDI recurrence before the end of the study was observed in 11.8% (9/76) of fidaxomicin-treated patients and 29.0% (9/31) of vancomycin-treated patients [43]. Therefore, as for the phase 3 fidaxomicin trial in adults, fidaxomicin was associated with a lower CDI recurrence rate in children [43]. The SUNSHINE trial will guide the design of future trials that optimize CDI case ascertainment in children and limit bias potentially related to the enrolment of those with alternative and/or concomitant diarrhoeal aetiologies in CDI [42].…”
Section: The Role Of Fidaxomicinmentioning
confidence: 94%
“…The number of patients with treatment-emergent adverse events (TEAEs) appeared similar between treatment arms and between age groups [41]. While the number of patients who reached a confirmed clinical response at 2 days after the end of treatment was 77.6% (76/98) in the fidaxomicin arm and 70.5% (31/44) in the vancomycin arm, CDI recurrence before the end of the study was observed in 11.8% (9/76) of fidaxomicin-treated patients and 29.0% (9/31) of vancomycin-treated patients [43]. Therefore, as for the phase 3 fidaxomicin trial in adults, fidaxomicin was associated with a lower CDI recurrence rate in children [43].…”
Section: The Role Of Fidaxomicinmentioning
confidence: 97%
“…Fidaxomicin, an oral narrow anti-C. difficile macrocyclic antibiotic was approved for its use in paediatric patients with CDI by the Food and Drug Administration (FDA) and European J o u r n a l P r e -p r o o f medicines agency (EMA) based on the results of two registered industry-sponsored clinical trials [41][42][43][44]. The paediatric patients were defined as children with a bodyweight of at least 12.5 kg by EMA [44] and 6 months of age and older by FDA [43].…”
Section: Treatment Of the Initial Non-severe Clostridioides Difficile...mentioning
confidence: 99%