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Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Liver Transplantation, Fungal Infection

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Trial Information

Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Absence of breakthrough proven/probable invasive fungal infection by day +100

Principal Investigator

Jesus Fortun, MD

Investigator Role:

Study Director

Investigator Affiliation:

Hospital Ramon y Cajal, Madrid, Spain

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GESITRA-01

NCT ID:

NCT00333645

Start Date:

October 2003

Completion Date:

March 2007

Related Keywords:

  • Liver Transplantation
  • Fungal Infection
  • Liver transplantation
  • Invasive fungal infection
  • Invasive aspergillosis
  • Prophylaxis
  • Caspofungin
  • Mycoses

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