Abstract:In recently updated international guidelines, fidaxomicin is preferentially recommended as first-line treatment over vancomycin both for the first episode of CDI and for rCDI, based on the results of different randomized controlled trials (RCTs). Although noninferiority was the rule in phase-3 RCTs with regard to the primary endpoint of clinical cure, for shaping these recommendations, particular attention was devoted to the improved global cure and reduced risk of recurrent CDI (rCDI) observed with fidaxomici… Show more
“…Another study [ 14 ] with a higher percentage of patients treated in the first episode replicated the results of the pivotal trials. Nevertheless, all these post-authorization studies [ 12 , 14 , 26 , 27 ] confirmed the outcomes in both clinical cure and recurrence rate that appeared in the RCT [ 9 , 10 ] varying from 82% to 92% cure [ 12 , 14 , 26 , 27 ], with recurrence rate from 15% to 28% [ 12 , 14 , 16 , 26 , 28 ], similar to our results (cure 84% and recurrence 33% in fidaxomicin group). In addition, Gentry et al reported higher failure rates in patients with severe CDI treated with fidaxomicin compared to vancomycin (9.39% vs. 1.41%), as well as higher combined outcome clinical failure or recurrence at 12 weeks (32% in fidaxomicin vs 25% in vancomycin) [ 16 ].…”
Background
Clostridioides difficile
infection (CDI) is a major cause of diarrhea in hospitalized adult patients. This study aims to evaluate the clinical characteristics, clinical cure, recurrence and mortality in patients with CDI treated with either fidaxomicin or vancomycin.
Methods
A retrospective case-control study was conducted on patients with CDI treated with either fidaxomicin or vancomycin at a hospital from January 2019 to March 2022.
Results
We assessed 140 patients with CDI episodes, 70 patients treated with fidaxomicin and 70 with vancomycin. Seventy (50%) were male. Median age was 70 years old (IQR: 56-81). Fidaxomicin group had more recurrent CDI episodes within six months (59% vs 11%, p ≤ 0.001), more severity (43% vs 16%, p ≤ 0.001) and less treatment response (84% vs 100%, p ≤ 0.002) compared with vancomycin group. Recurrence and mortality rates in the follow-up period did not differ in both groups.
Conclusions
Our study found fidaxomicin treatment had worse outcomes due to restricted usage, potentially impacting its effectiveness in CDI. This finding is especially significant for patients with severe or recurrent CDI, as prescribing of the drug was limited until May 2022 in Spain with the lifting of this restriction, further research is necessary to better understand the potential benefits of fidaxomicin in treating CDI.
“…Another study [ 14 ] with a higher percentage of patients treated in the first episode replicated the results of the pivotal trials. Nevertheless, all these post-authorization studies [ 12 , 14 , 26 , 27 ] confirmed the outcomes in both clinical cure and recurrence rate that appeared in the RCT [ 9 , 10 ] varying from 82% to 92% cure [ 12 , 14 , 26 , 27 ], with recurrence rate from 15% to 28% [ 12 , 14 , 16 , 26 , 28 ], similar to our results (cure 84% and recurrence 33% in fidaxomicin group). In addition, Gentry et al reported higher failure rates in patients with severe CDI treated with fidaxomicin compared to vancomycin (9.39% vs. 1.41%), as well as higher combined outcome clinical failure or recurrence at 12 weeks (32% in fidaxomicin vs 25% in vancomycin) [ 16 ].…”
Background
Clostridioides difficile
infection (CDI) is a major cause of diarrhea in hospitalized adult patients. This study aims to evaluate the clinical characteristics, clinical cure, recurrence and mortality in patients with CDI treated with either fidaxomicin or vancomycin.
Methods
A retrospective case-control study was conducted on patients with CDI treated with either fidaxomicin or vancomycin at a hospital from January 2019 to March 2022.
Results
We assessed 140 patients with CDI episodes, 70 patients treated with fidaxomicin and 70 with vancomycin. Seventy (50%) were male. Median age was 70 years old (IQR: 56-81). Fidaxomicin group had more recurrent CDI episodes within six months (59% vs 11%, p ≤ 0.001), more severity (43% vs 16%, p ≤ 0.001) and less treatment response (84% vs 100%, p ≤ 0.002) compared with vancomycin group. Recurrence and mortality rates in the follow-up period did not differ in both groups.
Conclusions
Our study found fidaxomicin treatment had worse outcomes due to restricted usage, potentially impacting its effectiveness in CDI. This finding is especially significant for patients with severe or recurrent CDI, as prescribing of the drug was limited until May 2022 in Spain with the lifting of this restriction, further research is necessary to better understand the potential benefits of fidaxomicin in treating CDI.
“…In the IDSA/SHEA guideline updates, a significant consideration is introduced regarding the recommendation of fidaxomicin over a standard course of vancomycin for initial CDI treatment – specifically, the choice of fidaxomicin hinges on resource availability [ 7 ]. The considerable cost associated with fidaxomicin has indeed posed a barrier to its widespread adoption [ 5 , 11 ]. Consequently, the IDSA/SHEA guidelines deem vancomycin as an acceptable alternative to fidaxomicin for patients with an initial CDI [ 7 ].…”
Section: Resultsmentioning
confidence: 99%
“…Furthermore, the FDA advises caution in administering bezlotoxumab, emphasising that it should be considered only when the benefits outweigh the risks in patients with a history of congestive heart failure [ 7 ]. Additionally, there remains limited knowledge regarding the efficacy of fidaxomicin in combination with bezlotoxumab for preventing recurrent CDI [ 5 ].…”
Clostridioides difficile
infection (CDI) poses a persistent challenge in healthcare, with substantial morbidity and mortality implications. This comprehensive review explores current CDI management, emphasising guidelines from IDSA, SHEA, and ESCMID. Additionally, this study spotlights recent drug developments that have the potential to reshape CDI treatment paradigms. Within the current treatment landscape, fidaxomicin, vancomycin, bezlotoxumab, and faecal microbiota transplantation offer varied options, each with its unique strengths and limitations. Fidaxomicin, effective yet resource-constrained, presents a dilemma, with vancomycin emerging as a pragmatic alternative. Bezlotoxumab, though augmenting antibiotics, grapples with cost and safety concerns. Meanwhile, faecal microbiota transplantation, highly efficacious, confronts evolving safety considerations. The horizon of CDI treatment also features promising therapies such as SER-109 and Rebyota, epitomising the evolving paradigm. As CDI management advances, the critical role of standardised microbiome restoration therapies becomes evident, ensuring long-term safety and diversifying treatment strategies.
“…Indeed, the benefit has been demonstrated to be higher in most fragile patients [46,47]. Risk group stratification strategies are needed to identify patients who are most likely to benefit from fidaxomicin [48].…”
Clostridioides difficile infection (CDI) is a significant cause of morbidity and mortality, mostly in frail patients. Notification is not mandatory in Italy, and data on incidence, risk of death, and recurrence are lacking. The purpose of this study was to determine CDI incidence and risk factors for mortality and recurrence. The “ICD-9 00845” code in hospital-standardized discharged forms (H-SDF) and microbiology datasets were used to retrieve CDI cases at Policlinico Hospital, Palermo between 2013 and 2022. Incidence, ward distribution, recurrence rate, mortality, and coding rate were considered. The risk of death and recurrence was predicted through multivariable analysis. There were 275 CDIs, 75% hospital-acquired, the median time between admission and diagnosis was 13 days, and the median stay was 21 days. Incidence increased from 0.3 to 5.6% (an 18.7-fold increase) throughout the decade. Only 48.1% of cases were coded in H-SDF. The rate of severe/severe-complicated cases increased 1.9 times. Fidaxomicin was used in 17.1% and 24.7% of cases overall and since 2019. Overall and attributable mortalities were 11.3% and 4.7%, respectively. Median time between diagnosis and death was 11 days, and recurrence rate was 4%. Bezlotoxumab was administered in 64% of recurrences. Multivariable analysis revealed that only hemodialysis was associated with mortality. No statistically significant association in predicting recurrence risk emerged. We advocate for CDI notification to become mandatory and recommend coding CDI diagnosis in H-SDF to aid in infection rate monitoring. Maximum attention should be paid to preventing people on hemodialysis from getting CDI.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.