Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial

Cornely, Oliver A.; Crook, Derrick W.; Esposito, Roberto; Poirier, André; Somero, Michael; Weiss, Karl Heinz; Sears, P.S.; Gorbach, Sherwood L.

doi:10.1016/s1473-3099(11)70374-7

Cited by 656 publications

(702 citation statements)

References 21 publications

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“…On the basis of two RCTs with oral vancomycin, the FDA granted approval for fi daxomicin in May 2011 ( 53,54 ). In both published phase III trials, fi daxomicin demonstrated non-inferiority to vancomycin in the modifi ed intention-to-treat and the per-protocol analyses for clinical response at the end of therapy and at 25 days post therapy.…”

Section: Management Of Mild Moderate and Severe CDImentioning

confidence: 99%

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Surawicz

Brandt

Binion

et al. 2013

American Journal of Gastroenterology

1,467

1,408

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Clostridium diffi cile infection (CDI) is a leading cause of hospital-associated gastrointestinal illness and places a high burden on our health-care system. Patients with CDI typically have extended lengths-of-stay in hospitals, and CDI is a frequent cause of large hospital outbreaks of disease. This guideline provides recommendations for the diagnosis and management of patients with CDI as well as for the prevention and control of outbreaks while supplementing previously published guidelines. New molecular diagnostic stool tests will likely replace current enzyme immunoassay tests. We suggest treatment of patients be stratifi ed depending on whether they have mild-to-moderate, severe, or complicated disease. Therapy with metronidazole remains the choice for mildto-moderate disease but may not be adequate for patients with severe or complicated disease. We propose a classifi cation of disease severity to guide therapy that is useful for clinicians. We review current treatment options for patients with recurrent CDI and recommendations for the control and prevention of outbreaks of CDI. Am J Gastroenterol 2013; 108:478-498; doi: 10.1038/ajg.2013 12. In patients in whom oral antibiotics cannot reach a segment of the colon, such as with Hartman's pouch, ileostomy, or colon diversion, vancomycin therapy delivered via enema should be added to treatments above until the patient improves. (Conditional recommendation, low-quality evidence)13. The use of anti-peristaltic agents to control diarrhea from confi rmed or suspected CDI should be limited or avoided, as they may obscure symptoms and precipitate complicated disease. Use of anti-peristaltic agents in the setting of CDI must always be accompanied by medical therapy for CDI. (Strong recommendation, low-quality evidence) Management of severe and complicated CDI14. Supportive care should be delivered to all patients and includes intravenous fl uid resuscitation, electrolyte replacement, and pharmacological venous thromboembolism prophylaxis. Furthermore, in the absence of ileus or signifi cant abdominal distention, oral or enteral feeding should be continued. 17. Vancomycin delivered orally (500 mg four times per day) and per rectum (500 mg in a volume of 500 ml four times a day) plus intravenous metronidazole (500 mg three times a day) is the treatment of choice for patients with complicated CDI with ileus or toxic colon and / or signifi cant abdominal distention. (Strong recommendation, low-quality evidence)18. Surgical consult should be obtained in all patients with complicated CDI. Surgical therapy should be considered in patients with any one of the following attributed to CDI: hypotension requiring vasopressor therapy; clinical signs of sepsis and organ dysfunction (renal and pulmonary); mental status changes; white blood cell count ≥ 50,000 cells / μ l, lactate ≥ 5 mmol / l; or failure to improve on medical therapy after 5 days. (Strong recommendation, moderate-quality evidence) Management of recurrent CDI (RCDI)19. The fi rst recurrence of CDI can be treated ...

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Section: Management Of Mild Moderate and Severe CDImentioning

confidence: 99%

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Surawicz

Brandt

Binion

et al. 2013

American Journal of Gastroenterology

1,467

1,408

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“…It is bactericidal and demonstrates prolonged post-antibiotic effects against C. difficile. 35 Fidaxomicin has been shown to be safe and effective for the first episode of C. difficile infection 36,37 ; however, there is limited evidence for recurrent infection.…”

Section: Fidaxomicinmentioning

confidence: 99%

“…36,37 Approximately 16% of the patients had had a previous episode of infection. Both trials found that 10 days of oral fidaxomicin (200 mg twice daily) was noninferior to 10 days of oral vancomycin (125 mg 4 times daily) in terms of clinical cure.…”

Section: J H P -Vol 66 No 6 -November-december 2013 J C P H -Volmentioning

confidence: 99%

Treatment Strategies for Recurrent Clostridium difficile Infection

Leong

Zelenitsky

2013

CJHP

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“…5,6 Currently, standard treatment of severe CDI is the use of vancomycin, metronidazole or fidaxomicin. [7][8][9] While effective, these antibiotics may contribute to a very high recurrence rate ranging from 20-35%. 10,11 A recent computer simulation shows that vaccination could be the cost-effective approach in the prevention and treatment of CDI, especially the recurrent CDI.…”

Section: Introductionmentioning

confidence: 99%

A chimeric protein comprising the glucosyltransferase and cysteine proteinase domains of toxin B and the receptor binding domain of toxin A induces protective immunity againstClostridium difficileinfection in mice and hamsters

Wang

Yan

Kim

et al. 2015

Human Vaccines & Immunotherapeutics

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Fidaxomicin versus vancomycin for infection with Clostridium difficile in Europe, Canada, and the USA: a double-blind, non-inferiority, randomised controlled trial

Cited by 656 publications

References 21 publications

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Guidelines for Diagnosis, Treatment, and Prevention of Clostridium difficile Infections

Treatment Strategies for Recurrent Clostridium difficile Infection

A chimeric protein comprising the glucosyltransferase and cysteine proteinase domains of toxin B and the receptor binding domain of toxin A induces protective immunity againstClostridium difficileinfection in mice and hamsters

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