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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54CK000162 | U.S. NIH Grant/Contract | View source |
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Study not performed
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| Name | Class |
|---|---|
| Centers for Disease Control and Prevention | FED |
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The purpose of this research study is to evaluate the effectiveness of an antibiotic called fidaxomicin in preventing C. difficile infection.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fidaxomicin | Experimental | Receive 200 mg of fidaxomicin twice daily |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fidaxomicin | Drug | Receive 200 mg of fidaxomicin twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clostridium difficile | Clostridium difficile isolated from patient stool specimen | At discharge from hospital (average of 7 days after enrollment in study) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19780659 | Background | Belmares J, Johnson S, Parada JP, Olson MM, Clabots CR, Bettin KM, Peterson LR, Gerding DN. Molecular epidemiology of Clostridium difficile over the course of 10 years in a tertiary care hospital. Clin Infect Dis. 2009 Oct 15;49(8):1141-7. doi: 10.1086/605638. | |
| 19780660 | Background | 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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| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077732 | Fidaxomicin |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D061065 | Polyketides |
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| Placebo | Drug | Receive Placebo twice daily |
|
| 20647790 | Background | Bobo LD, Dubberke ER. Recognition and prevention of hospital-associated enteric infections in the intensive care unit. Crit Care Med. 2010 Aug;38(8 Suppl):S324-34. doi: 10.1097/CCM.0b013e3181e69f05. |
| 19419269 | Background | 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. |
| 18598621 | Background | Dubberke ER, Butler AM, Reske KA, Agniel D, Olsen MA, D'Angelo G, McDonald LC, Fraser VJ. Attributable outcomes of endemic Clostridium difficile-associated disease in nonsurgical patients. Emerg Infect Dis. 2008 Jul;14(7):1031-8. doi: 10.3201/eid1407.070867. |
| 20100085 | Background | Dubberke ER, Butler AM, Yokoe DS, Mayer J, Hota B, Mangino JE, Khan YM, Popovich KJ, Stevenson KB, McDonald LC, Olsen MA, Fraser VJ; Prevention Epicenters Program of the Centers for Disease Control and Prevention. Multicenter study of surveillance for hospital-onset Clostridium difficile infection by the use of ICD-9-CM diagnosis codes. Infect Control Hosp Epidemiol. 2010 Mar;31(3):262-8. doi: 10.1086/650447. |
| 18840091 | Background | 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. |
| 19239377 | Background | 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. |
| 17577478 | Background | 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. |
| 17533213 | Background | 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. |
| 19049438 | Background | 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. |
| 18955525 | Background | 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. |
| 21288078 | Background | Louie TJ, Miller MA, Mullane KM, Weiss K, Lentnek A, Golan Y, Gorbach S, Sears P, Shue YK; OPT-80-003 Clinical Study Group. Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J Med. 2011 Feb 3;364(5):422-31. doi: 10.1056/NEJMoa0910812. |
| D047028 |
| Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |