Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00333645
• Other study ID #: GESITRA-01
• Secondary ID: 03-0409 (Spanish
• Status: Recruiting
• Phase: Phase 2
• First received: June 4, 2006
• Last updated: April 12, 2007
• Start date: October 2003
• Est. completion date: March 2007

Study information

• Verified date: December 2006
• Source: Grupo de Estudio de Infecciones en Transplantados
• Contact: Jesus Fortun, MD, PhD
• Phone: +34-670-537460
• Email: fortun[@]mi.madritel.es
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Fungal Infection
• Infection
• Liver Transplantation
• Mycoses

Intervention

Drug:
• Caspofungin

Locations

Country	Name	City	State
Spain	Hospital de Cruces	Barakaldo
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Complejo Hospitalario Reina Sofia	Cordoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Complejo Hospitalario Juan Canalejo	La Coruña
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Universitario Puerta de Hierro	Madrid
Spain	Complejo Hospitalario Carlos Haya	Malaga
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario La Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Grupo de Estudio de Infecciones en Transplantados	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of breakthrough proven/probable invasive fungal infection by day +100
Secondary	Absence of breakthrough proven/probable invasive aspergillosis by day +100
Secondary	Discontinuation of study therapy due to a drug-related adverse event
Secondary	Incidence of drug-related serious adverse event(s)
Secondary	Incidence of drug-related adverse event(s)