Safety and Efficacy of Fidaxomicin in Patients with Clostridium Difficile Infection

2013 ◽  
Vol 5 ◽  
pp. CMT.S7279
Author(s):  
Monica A. Donnelley ◽  
Jeremiah J. Duby ◽  
Christine S. Cocanour
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Systemic Absorption ◽  
Oral Vancomycin ◽  
Recurrence Rates ◽  
Virulent Strains ◽  
United States Food ◽  
The Cost ◽  
Healthcare Epidemiology ◽  
Systemic Infections

Fidaxomicin is a bactericidal macrolide that is indicated for the treatment of Clostridium difficile infection (CDI) in adults. Fidaxomicin is not effective for the treatment of systemic infections due to minimal systemic absorption. Until recently, oral vancomycin was the only medication with United States Food and Drug Administration (FDA) approval for the treatment of CDI. In clinical studies, fidaxomicin demonstrated noninferiority to vancomycin for the treatment of CDI. Lower recurrence rates of CDI with fidaxomicin than with oral vancomycin were observed. The lower recurrence rates were not observed with highly virulent strains of C. difficile. Lower recurrence rates of CDI with fidaxomicin are believed to be associated with its narrow spectrum of activity. Fidaxomicin was approved for use after publication of the most recent guideline from the Society for Healthcare Epidemiology of America (SHEA) and Infectious Diseases Society of America (IDSA). However, its current place in clinical practice is unknown. The cost of fidaxomicin should be considered when prescribing this medication.

Systemic absorption of oral vancomycin in patients with Clostridium difficile infection

2011 ◽  
Vol 43 (5) ◽  
pp. 386-388 ◽  
Author(s):  
Sriharsha Rao ◽  
Yizhak Kupfer ◽  
Murali Pagala ◽  
Edward Chapnick ◽  
Sidney Tessler
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Systemic Absorption ◽  
Oral Vancomycin

scholarly journals Zinc Level and Its Role in Recurrent Clostridium difficile Infection: A Case Report and Literature Review

2020 ◽  
Vol 8 ◽  
pp. 232470962094131
Author(s):  
Swetha Parvataneni ◽  
Avinash R. Dasari
Keyword(s):  
United States ◽  
Case Report ◽  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Zinc Supplementation ◽  
The United States ◽  
Zinc Level ◽  
Recurrence Rates ◽  
Oral Transmission ◽  
Recurrent Clostridium Difficile Infection

Clostridium difficile infection is a common nosocomial infection in US hospitals, accounting for approximately 12 800 deaths annually in the United States. These infections are often associated with the use of antibiotics, which can alter the gut microbiome and thus render patients susceptible to C difficile infection. C difficile is often spread via fecal oral transmission. Multiple medications have been developed, but recurrence rates reach 60% after treatment. Recent data have shown that zinc supplementation decreases the recurrence of C difficile infection. In this article, we present a case of recurrent C difficile infection with zinc deficiency in which zinc supplementation improved the symptoms and reduced the incidence of recurrence.

scholarly journals Safety and Efficacy of Fidaxomicin and Vancomycin in Children and Adolescents with Clostridioides (Clostridium) difficile Infection: A Phase 3, Multicenter, Randomized, Single-blind Clinical Trial (SUNSHINE)

2019 ◽  
Vol 71 (10) ◽  
pp. 2581-2588 ◽  
Author(s):  
Joshua Wolf ◽  
Krisztina Kalocsai ◽  
Claudia Fortuny ◽  
Stefan Lazar ◽  
Samantha Bosis ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Adverse Events ◽  
Children And Adolescents ◽  
Clostridium Difficile Infection ◽  
Systemic Absorption ◽  
Phase 3 ◽  
Safety And Efficacy ◽  
Parallel Group ◽  
End Of Treatment ◽  
Parallel Group Trial

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 randomized 2:1 to 10 days of treatment with fidaxomicin (suspension or tablets, twice daily) or vancomycin (suspension or tablets, 4 times daily). Safety assessments included treatment-emergent adverse events. The primary efficacy end point was confirmed clinical response (CCR), 2 days after the end of treatment (EOT). Secondary end points included global cure (GC; CCR without CDI recurrence) 30 days after EOT (end of study; EOS). Plasma and stool concentrations of fidaxomicin and its active metabolite OP-1118 were measured. Results Of 148 patients randomized, 142 were treated (30 <2 years old). The proportion of participants with treatment-emergent adverse events was similar with fidaxomicin (73.5%) and vancomycin (75.0%). Of 3 deaths in the fidaxomicin arm during the study, none were CDI or treatment related. The rate of CCR at 2 days after EOT was 77.6% (76 of 98 patients) with fidaxomicin and 70.5% (31 of 44) with vancomycin, whereas the rate of GC at EOS was significantly higher in participants receiving fidaxomicin (68.4% vs 50.0%; adjusted treatment difference, 18.8%; 95% confidence interval, 1.5%–35.3%). Systemic absorption of fidaxomicin and OP-1118 was minimal, and stool concentrations were high. Conclusions Compared with vancomycin, fidaxomicin was well tolerated and demonstrated significantly higher rates of GC in children and adolescents with CDI. Clinical Trials Registration NCT02218372

scholarly journals 1110. A multicenter Evaluation of Outcomes Associated With Oral Vancomycin Dose in Patients With Clostridium difficile Infection

2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S333-S333
Author(s):  
Monique Bidell ◽  
Gregory Novak ◽  
Gurkirat Singh ◽  
Benjamin Bratek ◽  
Odirichukwu Duru ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Standard Dose ◽  
Univariate Analysis ◽  
Fecal Microbiota ◽  
P Value ◽  
High Dose ◽  
Oral Vancomycin ◽  
Symptomatic Infection ◽  
Fecal Microbiota Transplant

Abstract Background Clostridium difficile infection (CDI) is a significant cause of morbidity and mortality. IDSA guidelines recommend oral vancomycin (VAN) for the treatment of CDI, although doses used in practice vary substantially. The purpose of this study was to determine differences in outcomes between patients treated with high dose (HD; ≥250 mg four times daily [QID]) vs. standard dose (SD; 125 mg QID) VAN for CDI. Methods This multicenter study evaluated patients at two hospitals in Albany, NY diagnosed with CDI and treated with oral VAN between January 2013 and August 2017. Hospitalized patients were included if: age ≥18 years, positive C. difficile toxin polymerase chain reaction (PCR), symptomatic infection (e.g., new onset or increased frequency of loose stools), and received ≥48 hours of VAN QID. Patients were excluded if: received ≥48 hours of metronidazole prior to VAN initiation, VAN per rectum, required surgical intervention ≤48 hours from PCR, had a history of fecal microbiota transplant, received ≥1 dose of fidaxomicin or tigecycline prior to or within 48 hours from PCR, or died ≤48 hours from PCR. The primary outcome was 90-day CDI recurrence; secondary outcomes included 30-day all-cause mortality and 90-day readmission. Variables with a P-value <0.2 in univariate analysis were evaluated in multivariate (MV) analyses. Results Four hundred fifty-eight patients were included (site 1: 270; site 2: 188). Two hundred twenty-four patients received SD VAN (48.9%); 234 received HD VAN [250 mg QID: 199 (43.5%); 500 mg QID: 35 (7.6%)]. Baseline demographics were similar between groups. Patients treated with HD were more likely to present with colitis (19.2 vs. 29.5%, P = 0.01) and have higher infection severity based on IDSA (P < 0.01), Zar (P < 0.01), and American College of Gastroenterology (P < 0.02) criteria. Modified APACHE II scores were similar between SD and HD groups (median: 12.2 vs. 12.9, P = 0.17). MV analysis identified no difference in 90-day recurrence with HD (OR 1.65, P = 0.13) after controlling for solid tumor cancers, immunosuppression, and IDSA severity. Similarly, no significant differences between SD and HD were observed for 30-day mortality and 90-day readmission. Conclusion No differences in recurrence, mortality, or readmission were identified between SD and HD oral VAN for the treatment of CDI, though HD VAN patients primarily received 250 mg QID. Disclosures All authors: No reported disclosures.

scholarly journals Decreased Cure and Increased Recurrence Rates for Clostridium difficile Infection Caused by the Epidemic C. difficile BI Strain

2012 ◽  
Vol 55 (3) ◽  
pp. 351-357 ◽  
Author(s):  
Laurica A. Petrella ◽  
Susan P. Sambol ◽  
Adam Cheknis ◽  
Kristin Nagaro ◽  
Yin Kean ◽  
...  
Keyword(s):  
Clostridium Difficile ◽  
Clostridium Difficile Infection ◽  
Recurrence Rates
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