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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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 Marañón
        • 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 Rocío
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Absence of breakthrough proven/probable invasive fungal infection by day +100

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo de Estudio de Infecciones en Transplantados

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2003

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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