Clinical trial NCT01552668: Fidaxomicin to Prevent Clostridium Difficile Colonization
Official title: The Effect of a Twice Daily, 200 mg Dose of Oral Fidaxomicin Compared to Placebo on Risk of Acquiring C. Difficile and Developing C. Difficile Infection (CDI) in High Risk Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Clostridium Difficile Infection
Keywords: Clostridium difficile infection
fidaxomicin
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2012-03-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.

Detailed description: A novel approach to prevent C. difficile infection is to use compounds with activity against C. difficile as primary prophylaxis in high risk patients. Chemoprophylaxis theoretically can prevent C. difficile infection by two mechanisms. It may reduce transmission from asymptomatic C. difficile carriers by reducing the number of spores shed in the stool and prevent replication and subsequent toxin production of the organisms in patients at risk for C. difficile infection.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years old
* On broad spectrum antimicrobials
* Anticipated length of stay of \> 48 hours after enrollment
* A non-ICU inpatient

Exclusion Criteria:

* Pregnant
* Expected to die within 7 days
* Have previously been enrolled in this trial or a trial of an investigational agent to treat CDI, and/or are on monotherapy with an antimicrobial generally considered not to increase the risk of CDI (vanc, macrolides, tetracyclines, trimethoprim/sulfamethoxazole, aminoglycosides, colistin, linezolid, nitrofurantoin, metronidazole)

Primary outcomes:
measure: Clostridium difficile
timeFrame: At discharge from hospital (average of 7 days after enrollment in study)
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
References:
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citation: Dubberke ER. The A, B, BI, and Cs of Clostridium difficile. Clin Infect Dis. 2009 Oct 15;49(8):1148-52. doi: 10.1086/605639. No abstract available.
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citation: Dubberke ER, Butler AM, Hota B, Khan YM, Mangino JE, Mayer J, Popovich KJ, Stevenson KB, Yokoe DS, McDonald LC, Jernigan J, Fraser VJ; Prevention Epicenters Program from the Centers for Disease Control and Prevention. Multicenter study of the impact of community-onset Clostridium difficile infection on surveillance for C. difficile infection. Infect Control Hosp Epidemiol. 2009 Jun;30(6):518-25. doi: 10.1086/597380.
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citation: Dubberke ER, Gerding DN, Classen D, Arias KM, Podgorny K, Anderson DJ, Burstin H, Calfee DP, Coffin SE, Fraser V, Griffin FA, Gross P, Kaye KS, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent clostridium difficile infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S81-92. doi: 10.1086/591065. No abstract available.
citation: Dubberke ER, McMullen KM, Mayfield JL, Reske KA, Georgantopoulos P, Warren DK, Fraser VJ. Hospital-associated Clostridium difficile infection: is it necessary to track community-onset disease? Infect Control Hosp Epidemiol. 2009 Apr;30(4):332-7. doi: 10.1086/596604.
citation: Dubberke ER, Reske KA, Noble-Wang J, Thompson A, Killgore G, Mayfield J, Camins B, Woeltje K, McDonald JR, McDonald LC, Fraser VJ. Prevalence of Clostridium difficile environmental contamination and strain variability in multiple health care facilities. Am J Infect Control. 2007 Jun;35(5):315-8. doi: 10.1016/j.ajic.2006.12.006.
citation: Dubberke ER, Reske KA, Olsen MA, McMullen KM, Mayfield JL, McDonald LC, Fraser VJ. Evaluation of Clostridium difficile-associated disease pressure as a risk factor for C difficile-associated disease. Arch Intern Med. 2007 May 28;167(10):1092-7. doi: 10.1001/archinte.167.10.1092.
citation: Dubberke ER, Wertheimer AI. Review of current literature on the economic burden of Clostridium difficile infection. Infect Control Hosp Epidemiol. 2009 Jan;30(1):57-66. doi: 10.1086/592981.
citation: Louie T, Miller M, Donskey C, Mullane K, Goldstein EJ. Clinical outcomes, safety, and pharmacokinetics of OPT-80 in a phase 2 trial with patients with Clostridium difficile infection. Antimicrob Agents Chemother. 2009 Jan;53(1):223-8. doi: 10.1128/AAC.01442-07. Epub 2008 Oct 27.
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