Clinical trial NCT00333645: Prophylaxis With Caspofungin in High-Risk Liver Transplantation
Official title: Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Liver Transplantation
Fungal Infection
Keywords: Liver transplantation
Invasive fungal infection
Invasive aspergillosis
Prophylaxis
Caspofungin
Lead sponsor: Grupo de Estudio de Infecciones en Transplantados
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2006-06-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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 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%.


Eligibility 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.

Primary outcomes:
measure: Absence of breakthrough proven/probable invasive fungal infection by day +100
Secondary outcomes:
measure: Absence of breakthrough proven/probable invasive aspergillosis by day +100
measure: Discontinuation of study therapy due to a drug-related adverse event
measure: Incidence of drug-related serious adverse event(s)
measure: Incidence of drug-related adverse event(s)
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Cordoba
country: Spain
facility: Complejo Hospitalario Reina Sofia
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: La Coruña
country: Spain
facility: Complejo Hospitalario Juan Canalejo
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramon y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Malaga
country: Spain
facility: Complejo Hospitalario Carlos Haya
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
Study officials:
affiliation: Hospital Ramon y Cajal, Madrid, Spain
name: Jesus Fortun, MD
role: STUDY_DIRECTOR
References:
citation: 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].