Status:
UNKNOWN
Prophylaxis With Caspofungin in High-Risk Liver Transplantation
Lead Sponsor:
Grupo de Estudio de Infecciones en Transplantados
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Liver Transplantation
Fungal Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00333645
Start Date
October 1 2003
End Date
March 1 2007
Last Update
April 13 2007
Active Locations (13)
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1
Complejo Hospitalario Juan Canalejo
A Coruña, Spain, E-15006
2
Hospital de Cruces
Barakaldo, Spain, E-48903
3
Hospital Universitari Vall d'Hebron
Barcelona, Spain, E-08035
4
Complejo Hospitalario Reina Sofia
Córdoba, Spain, E-14004