Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nina Singh, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00841971
First received: February 11, 2009
Last updated: December 9, 2013
Last verified: December 2013

February 11, 2009
December 9, 2013
February 2010
July 2013   (final data collection date for primary outcome measure)
Frequency of fungal infection [ Time Frame: 90 days post enrollment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00841971 on ClinicalTrials.gov Archive Site
Need for additional antifungal therapy [ Time Frame: 90 days post enrollment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients
Anidulafungin Versus Fluconazole for the Prevention of Invasive Fungal Infections in High-risk Liver Transplant Recipients: a Randomized, Double-blind Trial

The purpose of this study is to compare the efficacy of anidulafungin versus fluconazole for the prevention of fungal diseases in liver transplant recipients

A number of well characterized risk factors have been shown to portend a high risk of opportunistic mycoses after liver transplantation.

Retransplantation and renal failure are amongst the most significant risk factors for invasive fungal infections in these patients.

Most Invasive fungal infections in these high-risk patients occur within the first month posttransplant.

Studies utilizing universal prophylaxis have primarily employed fluconazole. A recent meta-analysis of prophylactic trials documented a beneficial effect on morbidity and attributable mortality, but an emergence of infections due to non-albicans Candida spp. in patients receiving prophylaxis.

The availability of echinocandins has led to an expanded armamentarium of antifungal drugs with a potentially promising role as agents for targeted prophylaxis for invasive fungal infections in high-risk liver transplant recipients. Anidulafungin is unique amongst echinocandins in that it is eliminated from the body almost exclusively through biotransformation by slow non-enzymatic degradation in the blood, without hepatic metabolism or renal elimination. Anidulafungin has demonstrated good safety profile. We hypothesize that anidulafungin will be more effective and a better tolerated antifungal prophylactic agent in this setting.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
  • Mycoses
  • Fungemia
  • Central Nervous System Fungal Infections
  • Lung Diseases, Fungal
  • Drug: Anidulafungin
    200 mg IV loading dose followed by 100 mg qd for 21 days
  • Drug: Fluconazole
    400 mg IV for 21 days
    Other Name: DIFLUCAN
  • Experimental: anidulafungin
    anti-fungal agent
    Intervention: Drug: Anidulafungin
  • Active Comparator: Fluconazole
    anti-fungal agent
    Intervention: Drug: Fluconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
March 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Liver transplant recipient at increased risk for infection increased risk include any of the following:
  • retransplantation
  • renal replacement therapy (dialysis),
  • post transplant abdominal surgery (within 21days)
  • receipt of corticosteroids for greater than 14 days within the 4 weeks -preceding transplant
  • ICU care for greater than 48 hours at the time of transplantation
  • colonization with Candida sps within 4 weeks of transplantation
  • requirement of 15 units or greater of packed red cell transfusions
  • Intraoperative time exceeding 6 hours

Exclusion Criteria:

  • Hypersensitivity to azole or echinocandin antifungal agents
  • receipt of systemic antifungal therapy within 4 weeks prior to transplantation
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00841971
PRO08110001
Yes
Nina Singh, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: Nina Singh, MD University of Pittaburgh, VA Pittsburgh Health Systems
University of Pittsburgh
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP