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Prophylaxis With Caspofungin in High-Risk Liver Transplantation

NCT ID: NCT00333645

Last Updated: 2007-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-03-31

Brief Summary

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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

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Conditions

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Liver Transplantation Fungal Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Caspofungin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Grupo de Estudio de Infecciones en Transplantados

OTHER

Sponsor Role lead

Principal Investigators

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Jesus Fortun, MD

Role: STUDY_DIRECTOR

Hospital Ramon y Cajal, Madrid, Spain

Locations

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Complejo Hospitalario Juan Canalejo

A Coruña, , Spain

Site Status RECRUITING

Hospital de Cruces

Barakaldo, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Complejo Hospitalario Reina Sofia

Córdoba, , Spain

Site Status WITHDRAWN

Hospital Universitario Virgen de las Nieves

Granada, , Spain

Site Status RECRUITING

Hospital General Universitario Gregorio Marañón

Madrid, , Spain

Site Status RECRUITING

Hospital Ramon y Cajal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Puerta de Hierro

Madrid, , Spain

Site Status RECRUITING

Hospital 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Complejo Hospitalario Carlos Haya

Málaga, , Spain

Site Status RECRUITING

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

Hospital Universitario La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jesus Fortun, MD, PhD

Role: CONTACT

[email protected]
+34-670-537460

References

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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].

Reference Type RESULT

Other Identifiers

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03-0409 (Spanish Drug Agency)

Identifier Type: -

Identifier Source: secondary_id

GESITRA-01

Identifier Type: -

Identifier Source: org_study_id