NCT01552668

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.2 years

First QC Date

March 8, 2012

Last Update Submit

May 27, 2014

Conditions

Clostridium Difficile Infection

Keywords

Clostridium difficile infectionfidaxomicin

Outcome Measures

Primary Outcomes (1)

  • Clostridium difficile

    Clostridium difficile isolated from patient stool specimen

    At discharge from hospital (average of 7 days after enrollment in study)

Study Arms (2)

Fidaxomicin

EXPERIMENTAL

Receive 200 mg of fidaxomicin twice daily

Drug: Fidaxomicin

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

FidaxomicinDRUG

Receive 200 mg of fidaxomicin twice daily

Also known as: Dificid
Fidaxomicin
PlaceboDRUG

Receive Placebo twice daily

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (13)

  • 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.

    PMID: 19780659BACKGROUND

  • 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.

    PMID: 19780660BACKGROUND

  • 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.

    PMID: 20647790BACKGROUND

  • 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.

    PMID: 19419269BACKGROUND

  • 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.

    PMID: 18598621BACKGROUND

  • 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.

    PMID: 20100085BACKGROUND

  • 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.

    PMID: 18840091BACKGROUND

  • 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.

    PMID: 19239377BACKGROUND

  • 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.

    PMID: 17577478BACKGROUND

  • 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.

    PMID: 17533213BACKGROUND

  • 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.

    PMID: 19049438BACKGROUND

  • 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.

    PMID: 18955525BACKGROUND

  • 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.

    PMID: 21288078BACKGROUND

MeSH Terms

Conditions

Clostridium Infections

Interventions

Fidaxomicin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2012

First Posted

March 13, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

US(1)