Prophylaxis With Caspofungin in High-Risk Liver Transplantation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Grupo de Estudio de Infecciones en Transplantados.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Grupo de Estudio de Infecciones en Transplantados
ClinicalTrials.gov Identifier:
NCT00333645
First received: June 4, 2006
Last updated: April 12, 2007
Last verified: December 2006

June 4, 2006
April 12, 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
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.
Both
18 Years and older
No
Contact: Jesus Fortun, MD, PhD +34-670-537460 fortun@mi.madritel.es
Spain
 
NCT00333645
GESITRA-01, 03-0409 (Spanish Drug Agency)
Not Provided
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