Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Condition(s) targeted: Liver Transplantation; Fungal Infection

Intervention: Caspofungin (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Grupo de Estudio de Infecciones en Transplantados

Official(s) and/or principal investigator(s):
Jesus Fortun, MD, Study Director, Affiliation: Hospital Ramon y Cajal, Madrid, Spain

Overall contact:
Jesus Fortun, MD, PhD, Phone: +34-670-537460, Email: fortun@mi.madritel.es

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%.

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

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

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

Secondary outcome:

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)

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Jesus Fortun, MD, PhD, Phone: +34-670-537460, Email: fortun@mi.madritel.es

Hospital de Cruces, Barakaldo E-48903, Spain; Recruiting
Miguel Montejo, MD, Principal Investigator

Hospital Universitari Vall d'Hebron, Barcelona E-08035, Spain; Recruiting
Joan Gavaldà, MD, Principal Investigator

Complejo Hospitalario Reina Sofia, Cordoba E-14004, Spain; Withdrawn

Hospital Universitario Virgen de las Nieves, Granada E-18014, Spain; Recruiting
Daniel Garrote, MD, Principal Investigator

Complejo Hospitalario Juan Canalejo, La Coruña E-15006, Spain; Recruiting
Pedro Llinares, MD, Principal Investigator

Hospital 12 de Octubre, Madrid E-28041, Spain; Recruiting
Rafael San Juan, MD, Principal Investigator

Hospital General Universitario Gregorio Marañón, Madrid E-28007, Spain; Recruiting
Patricia Muñoz, MD, Principal Investigator

Hospital Ramon y Cajal, Madrid E-28034, Spain; Recruiting
Jesus Fortun, MD, Principal Investigator

Hospital Universitario Puerta de Hierro, Madrid E-28035, Spain; Recruiting
Antonio Ramos, MD, Principal Investigator

Complejo Hospitalario Carlos Haya, Malaga E-29010, Spain; Recruiting
Cesar Aragon, MD, Principal Investigator

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela E-15706, Spain; Recruiting
Evaristo Varo, MD, Principal Investigator

Hospital Universitario Virgen del Rocío, Sevilla E-41013, Spain; Recruiting
Jose-Miguel Cisneros, MD, Principal Investigator

Hospital Universitario La Fe, Valencia E-46009, Spain; Recruiting
Marino Blanes, MD, Principal Investigator

Starting date: October 2003
Last updated: April 12, 2007