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Fidaxomicin to Prevent Clostridium Difficile Colonization

Primary Purpose

Clostridium Difficile Infection

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fidaxomicin
Placebo
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Clostridium Difficile Infection focused on measuring Clostridium difficile infection, fidaxomicin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Washington University in St. Louis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fidaxomicin

Placebo

Arm Description

Receive 200 mg of fidaxomicin twice daily

Outcomes

Primary Outcome Measures

Clostridium difficile
Clostridium difficile isolated from patient stool specimen

Secondary Outcome Measures

Full Information

First Posted
March 8, 2012
Last Updated
May 27, 2014
Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01552668
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Study not performed
Study Start Date
September 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clostridium Difficile Infection
Keywords
Clostridium difficile infection, fidaxomicin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fidaxomicin
Arm Type
Experimental
Arm Description
Receive 200 mg of fidaxomicin twice daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fidaxomicin
Other Intervention Name(s)
Dificid
Intervention Description
Receive 200 mg of fidaxomicin twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Receive Placebo twice daily
Primary Outcome Measure Information:
Title
Clostridium difficile
Description
Clostridium difficile isolated from patient stool specimen
Time Frame
At discharge from hospital (average of 7 days after enrollment in study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Washington University in St. Louis
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19780659
Citation
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.
Results Reference
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PubMed Identifier
19780660
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.
Results Reference
background
PubMed Identifier
20647790
Citation
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.
Results Reference
background
PubMed Identifier
19419269
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.
Results Reference
background
PubMed Identifier
18598621
Citation
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.
Results Reference
background
PubMed Identifier
20100085
Citation
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.
Results Reference
background
PubMed Identifier
18840091
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.
Results Reference
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PubMed Identifier
19239377
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.
Results Reference
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PubMed Identifier
17577478
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.
Results Reference
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PubMed Identifier
17533213
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.
Results Reference
background
PubMed Identifier
19049438
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.
Results Reference
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PubMed Identifier
18955525
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.
Results Reference
background
PubMed Identifier
21288078
Citation
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.
Results Reference
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Fidaxomicin to Prevent Clostridium Difficile Colonization

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