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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nina Singh, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00841971
First received: February 11, 2009
Last updated: December 15, 2014
Last verified: December 2014
Results First Received: December 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Mycoses
Fungemia
Central Nervous System Fungal Infections
Lung Diseases, Fungal
Interventions: Drug: Anidulafungin
Drug: Fluconazole

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anidulafungin

anti-fungal agent

Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days

Fluconazole

anti-fungal agent

Fluconazole: 400 mg IV for 21 days


Participant Flow:   Overall Study
    Anidulafungin     Fluconazole  
STARTED     100     100  
COMPLETED     98     99  
NOT COMPLETED     2     1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Anidulafungin

anti-fungal agent

Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days

Fluconazole

anti-fungal agent

Fluconazole: 400 mg IV for 21 days

Total Total of all reporting groups

Baseline Measures
    Anidulafungin     Fluconazole     Total  
Number of Participants  
[units: participants]
  100     100     200  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     89     89     178  
>=65 years     11     11     22  
Age  
[units: years]
Median (Inter-Quartile Range)
  58  
  (52 to 62)  
  58  
  (51 to 62)  
  58  
  (52 to 62)  
Gender  
[units: participants]
     
Female     33     28     61  
Male     67     72     139  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     27     38     65  
Not Hispanic or Latino     73     62     135  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     100     100     200  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Frequency of Fungal Infection   [ Time Frame: 90 days post enrollment ]

2.  Secondary:   Need for Additional Antifungal Therapy   [ Time Frame: 90 days post enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Nina Singh
Organization: University of Pittsburgh
phone: 412 360-1688
e-mail: nis5@pitt.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nina Singh, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00841971     History of Changes
Other Study ID Numbers: PRO08110001
Study First Received: February 11, 2009
Results First Received: December 8, 2014
Last Updated: December 15, 2014
Health Authority: United States: Institutional Review Board