Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Phase 2

• Conditions: Liver Transplantation; Fungal Infection

• Registration Number: NCT00333645
• Lead Sponsor: Grupo de Estudio de Infecciones en Transplantados

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2006-06-04
• Study First Submitted QC: 2006-06-04
• Study First Posted: 2006-06-06
• Status Verified: 2006-12
• Study Completion: 2007-03
• Last Update Submitted: 2007-04-12
• Last Update Posted: 2007-04-13

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (13)

Hospital Ramon y Cajal; 🇪🇸 Madrid, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Complejo Hospitalario Universitario de Santiago; 🇪🇸 Santiago de Compostela, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital de Cruces; 🇪🇸 Barakaldo, Spain

Complejo Hospitalario Juan Canalejo; 🇪🇸 La Coruña, Spain

Hospital Universitario Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Complejo Hospitalario Reina Sofia; 🇪🇸 Cordoba, Spain

Complejo Hospitalario Carlos Haya; 🇪🇸 Malaga, Spain