Prophylaxis With Caspofungin in High-Risk Liver Transplantation

April 12, 2007 updated by: Grupo de Estudio de Infecciones en Transplantados

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

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%.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

70

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barakaldo, Spain, E-48903
        • Recruiting
        • Hospital de Cruces
        • Principal Investigator:
          • Miguel Montejo, MD
      • Barcelona, Spain, E-08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
        • Principal Investigator:
          • Joan Gavaldà, MD
      • Cordoba, Spain, E-14004
        • Withdrawn
        • Complejo Hospitalario Reina Sofía
      • Granada, Spain, E-18014
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Principal Investigator:
          • Daniel Garrote, MD
      • La Coruña, Spain, E-15006
        • Recruiting
        • Complejo Hospitalario Juan Canalejo
        • Principal Investigator:
          • Pedro Llinares, MD
      • Madrid, Spain, E-28007
        • Recruiting
        • Hospital General Universitario Gregorio Maranon
        • Principal Investigator:
          • Patricia Muñoz, MD
      • Madrid, Spain, E-28034
        • Recruiting
        • Hospital Ramon y Cajal
        • Principal Investigator:
          • Jesus Fortun, MD
      • Madrid, Spain, E-28035
        • Recruiting
        • Hospital Universitario Puerta de Hierro
        • Principal Investigator:
          • Antonio Ramos, MD
      • Madrid, Spain, E-28041
        • Recruiting
        • Hospital 12 de Octubre
        • Principal Investigator:
          • Rafael San Juan, MD
      • Malaga, Spain, E-29010
        • Recruiting
        • Complejo Hospitalario Carlos Haya
        • Principal Investigator:
          • Cesar Aragon, MD
      • Santiago de Compostela, Spain, E-15706
        • Recruiting
        • Complejo Hospitalario Universitario de Santiago
        • Principal Investigator:
          • Evaristo Varo, MD
      • Sevilla, Spain, E-41013
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Principal Investigator:
          • Jose-Miguel Cisneros, MD
      • Valencia, Spain, E-46009
        • Recruiting
        • Hospital Universitario La Fe
        • Principal Investigator:
          • Marino Blanes, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Absence of breakthrough proven/probable invasive fungal infection by day +100

Secondary Outcome Measures

Outcome Measure
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo de Estudio de Infecciones en Transplantados

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Jesus Fortun, MD, Hospital Ramon y Cajal, Madrid, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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].

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

June 4, 2006

First Submitted That Met QC Criteria

June 4, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

April 13, 2007

Last Update Submitted That Met QC Criteria

April 12, 2007

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GESITRA-01
  • 03-0409 (Spanish Drug Agency)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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