Novel Fidaxomicin Treatment Regimens for Patients With Multiple Clostridium difficile Infection Recurrences That Are Refractory to Standard Therapies

Soriano, Melinda M.; Danziger, Larry H.; Gerding, Dale N.; Johnson, Stuart

doi:10.1093/ofid/ofu069

Cited by 40 publications

(21 citation statements)

References 24 publications

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“…[6] A similar success rate was seen in a study of 18 patients using various tapering regimens of fidaxomicin. [7] The largest study of fidaxomicin use in recurrent disease across 20 hospitals in Spain was by Feher and colleagues. [8] Their study population was similar in terms of underlying conditions, severity of cases and requirement for colectomy; however, only 44 of the 72 cases were for recurrent disease, with only 26 being treated for ≥2 recurrences.…”

Section: Discussionmentioning

confidence: 99%

Real-world use of fidaxomicin in a large UK tertiary hospital: how effective is it for treating recurrent disease?

Enoch

Santos

Phillips

et al. 2018

Journal of Hospital Infection

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All courses of fidaxomicin use in the study hospital were reviewed. It was used for first recurrence (six times), second recurrence (eight times) and one case of third recurrence. One patients received fidaxomicin as first-line treatment. Eight patients initially responded to therapy; of these, three patients were asymptomatic at 90 days, three patients remained asymptomatic at 30 days, and two patients had recurrences five and nine days after stopping therapy. Four patients failed to respond; of these, two patients required faecal transplantation and one patient required a colectomy. Two patients deteriorated and two patients died. Fidaxomicin was well tolerated. These findings suggest that the utility of fidaxomicin at this stage of infection is unclear.

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Section: Discussionmentioning

confidence: 99%

Real-world use of fidaxomicin in a large UK tertiary hospital: how effective is it for treating recurrent disease?

Enoch

Santos

Phillips

et al. 2018

Journal of Hospital Infection

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“…31 Although fidaxomycin and vancomycin are equal as initial therapies for CDI, the recurrence rate is lower with fidaxomicin than with vancomycin. [32][33][34][35] Its effects in rCDI have been described in observational studies 36,37 and in subgroups in clinical trials. 38 In this study, we compared the effects of FMT, fidaxomicin, and standard-dose vancomycin for rCDI.…”

mentioning

confidence: 99%

Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection

et al. 2019

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See Covering the Cover synopsis on page 1225. BACKGROUND & AIMS: Fecal microbiota transplantation (FMT) is recommended for treatment of recurrent Clostridium difficile infection (rCDI). We performed a single-center randomized trial to compare the effects of FMT with those of fidaxomicin and vancomycin. METHODS: We studied consecutive adults with rCDI seen at a gastroenterology clinic in Denmark from April 5, 2016 through June 10, 2018. Patients were randomly assigned to a group that received FMT, applied by colonoscopy or nasojejunal tube, after 4-10 days of vancomycin (125 mg 4 times daily; FMTv; n ¼ 24), 10 days of fidaxomicin (200 mg twice daily; n ¼ 24), or 10 days of vancomycin (125 mg 4 times daily; n ¼ 16). Patients who had rCDI after this course of treatment and patients who could not be randomly assigned to groups were offered rescue FMTv. The primary outcome was combined clinical resolution and a negative result from a polymerase chain reaction test for Clostridium difficile (CD) toxin 8 weeks after the allocated treatment. Secondary end points included clinical resolution at week 8. RESULTS: All 64 patients received their assigned treatment. The combination of clinical resolution and negative results from the test for CD were observed in 17 patients given FMTv (71%), 8 patients given fidaxomicin (33%), and 3 patients given vancomycin (19%; P ¼ .009 for FMTv vs fidaxomicin; P ¼ .001 for FMTv vs vancomycin; P ¼ .31 for fidaxomicin vs vancomycin). Clinical resolution was observed in 22 patients given FMTv (92%), 10 patients given fidaxomicin (42%), and 3 patients given vancomycin (19%; P ¼ .0002; P < .0001; P ¼ .13). Results did not differ significantly between patients who received FMTv as their initial therapy and patients who received rescue FMTv. There was 1 serious adverse event that might have been related to FMTv. CONCLUSIONS: In a randomized trial of patients with rCDI, we found the FMTv combination superior to fidaxomicin or vancomycin based on end points of clinical and microbiological resolution or clinical resolution alone. ClinicalTrials.gov, number NCT02743234; EudraCT, j.no 2015-003004-24.

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“…This diagram reviews the recommended treatment approaches for primary and recurrent CDI, depending on disease severity based on the 2018 IDSA/SHEA guidelines. Additionally, there is some evidence for fidaxomicin in place of rifaximin as a chaser for recurrent CDI and the EXTEND trial did show evidence for using extended‐pulsed fidaxomicin for primary CDI; however, this is not currently reflected in the guidelines …”

Section: Conventional Management Of CDImentioning

confidence: 99%

“…Additionally, studies have been done on using alternative fidaxomicin dosing regimens for treating primary and recurrent CDI by looking at clinical cure rate and recurrence reduction. Soriano et al . showed in a case study of patients with multiple recurrent CDI that only 2 out of 11 patients (18%) had recurrence when given fidaxomicin in a tapering dose regimen as compared with 3 of 8 patients (38%) who were given only fidaxomicin as a chaser twice daily for 10 days.…”

Section: Conventional Management Of CDImentioning

confidence: 99%

Novel therapies and preventative strategies for primary and recurrent Clostridium difficile infections

Dieterle

Rao

Young

2018

Annals of the New York Academy of Sciences

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Clostridium difficile is the leading infectious cause of antibiotic-associated diarrhea and colitis. Clostridium difficile infection (CDI) places a heavy burden on the health care system, with nearly half a million infections yearly and an approximate 20% recurrence risk after successful initial therapy. The high incidence has driven new research on improved prevention such as the emerging use of probiotics, intestinal microbiome manipulation during antibiotic therapies, vaccinations, and newer antibiotics that reduce the disruption of the intestinal microbiome. While the treatment of acute C. difficile is effective in most patients, it can be further optimized by adjuvant therapies that improve the initial treatment success and decrease the risk of subsequent recurrence. Lastly, the high risk of recurrence has led to multiple emerging therapies that target toxin activity, recovery of the intestinal microbial community, and elimination of latent C. difficile in the intestine. In summary, CDIs illustrate the complex interaction among host physiology, microbial community, and pathogen that requires specific therapies to address each of the factors leading to primary infection and recurrence.

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Novel Fidaxomicin Treatment Regimens for Patients With Multiple Clostridium difficile Infection Recurrences That Are Refractory to Standard Therapies

Abstract: Novel, post-vancomycin fidaxomicin chaser or fidaxomicin taper regimens may decrease subsequent CDI episodes and improve outcomes compared to standard 10 day treatment of mrCDI episodes with fidaxomicin, but randomized prospective comparative data are not yet available.

Cited by 40 publications

References 24 publications

Real-world use of fidaxomicin in a large UK tertiary hospital: how effective is it for treating recurrent disease?

Real-world use of fidaxomicin in a large UK tertiary hospital: how effective is it for treating recurrent disease?

Fecal Microbiota Transplantation Is Superior to Fidaxomicin for Treatment of Recurrent Clostridium difficile Infection

Novel therapies and preventative strategies for primary and recurrent Clostridium difficile infections

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