Prophylaxis With Caspofungin in High-Risk Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00333645
Recruitment Status : Unknown
Verified December 2006 by Grupo de Estudio de Infecciones en Transplantados.
Recruitment status was:  Recruiting
First Posted : June 6, 2006
Last Update Posted : April 13, 2007
Merck Sharp & Dohme Corp.
Information provided by:
Grupo de Estudio de Infecciones en Transplantados

June 4, 2006
June 6, 2006
April 13, 2007
October 2003
Not Provided
Absence of breakthrough proven/probable invasive fungal infection by day +100
Same as current
Complete list of historical versions of study NCT00333645 on Archive Site
  • Absence of breakthrough proven/probable invasive aspergillosis by day +100
  • Discontinuation of study therapy due to a drug-related adverse event
  • Incidence of drug-related serious adverse event(s)
  • Incidence of drug-related adverse event(s)
Same as current
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Prophylaxis With Caspofungin in High-Risk Liver Transplantation
Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients
This is a non-comparative, open, multisite prospective estimation study to evaluate the efficacy and safety of caspofungin in the prophylactic treatment of adults who have received an orthotopic liver transplant and are at high risk of developing an invasive fungal infection. It is expected that the proportion of high-risk liver transplant recipients who develop a documented (proven or probable per European Organization for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG] modified criteria) invasive fungal infection during the first 100 days after the onset of prophylaxis with caspofungin will be lower than 15%. It is also expected that the incidence of serious drug-related adverse events will be less than 25%.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Liver Transplantation
  • Fungal Infection
Drug: Caspofungin
Not Provided
Fortun J, Muñoz P, Cisneros JM, et al. Antifungal prophylaxis with caspofungin in high-risk liver transplant recipients: a noncomparative, open-label prospective clinical trial. Clinical Microbiology & Infection 12 (suppl. 4): P684, 2006. [Abstract on an interim analysis performed on the first 15 patients enrolled in the study, presented as a poster at 2006 ECCMID meeting].

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
March 2007
Not Provided

Inclusion Criteria:

  • 18 years of age or older
  • Patient has received an orthotopic liver transplantation
  • Patient meets criteria, as defined per protocol, for being considered at high risk of developing an invasive fungal infection post-liver transplantation
  • For women of childbearing potential, patient must have a negative serum or urine pregnancy test

Exclusion Criteria:

  • Any systemic antifungal therapy (other than fluconazole for a maximum of 7 days) within 14 days of the administration of the study drug.
  • Documented (proven/probable) or suspected (possible) invasive fungal infection at the time of enrollment.
  • Abnormal laboratory values as defined per protocol.
  • Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal.
  • Patient not expected to survive at least 5 days.
  • Patient is pregnant or breast feeding.
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
03-0409 (Spanish Drug Agency)
Not Provided
Not Provided
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Not Provided
Grupo de Estudio de Infecciones en Transplantados
Merck Sharp & Dohme Corp.
Study Director: Jesus Fortun, MD Hospital Ramon y Cajal, Madrid, Spain
Grupo de Estudio de Infecciones en Transplantados
December 2006

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