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Prophylaxis With Caspofungin in High-Risk Liver Transplantation

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ClinicalTrials.gov Identifier: NCT00333645
Recruitment Status : Unknown
Verified December 2006 by Grupo de Estudio de Infecciones en Transplantados.
Recruitment status was:  Recruiting
First Posted : June 6, 2006
Last Update Posted : April 13, 2007
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Grupo de Estudio de Infecciones en Transplantados

Study Description
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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%.

Condition or disease Intervention/treatment Phase
Liver Transplantation Fungal Infection Drug: Caspofungin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients
Study Start Date : October 2003
Study Completion Date : March 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Absence of breakthrough proven/probable invasive fungal infection by day +100

Secondary Outcome Measures :
  1. Absence of breakthrough proven/probable invasive aspergillosis by day +100
  2. Discontinuation of study therapy due to a drug-related adverse event
  3. Incidence of drug-related serious adverse event(s)
  4. Incidence of drug-related adverse event(s)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333645


Contacts
Contact: Jesus Fortun, MD, PhD +34-670-537460 fortun@mi.madritel.es

Locations
Spain
Hospital de Cruces Recruiting
Barakaldo, Spain, E-48903
Principal Investigator: Miguel Montejo, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, E-08035
Principal Investigator: Joan Gavaldà, MD         
Complejo Hospitalario Reina Sofia Withdrawn
Cordoba, Spain, E-14004
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, E-18014
Principal Investigator: Daniel Garrote, MD         
Complejo Hospitalario Juan Canalejo Recruiting
La Coruña, Spain, E-15006
Principal Investigator: Pedro Llinares, MD         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, E-28007
Principal Investigator: Patricia Muñoz, MD         
Hospital Ramon y Cajal Recruiting
Madrid, Spain, E-28034
Principal Investigator: Jesus Fortun, MD         
Hospital Universitario Puerta de Hierro Recruiting
Madrid, Spain, E-28035
Principal Investigator: Antonio Ramos, MD         
Hospital 12 de Octubre Recruiting
Madrid, Spain, E-28041
Principal Investigator: Rafael San Juan, MD         
Complejo Hospitalario Carlos Haya Recruiting
Malaga, Spain, E-29010
Principal Investigator: Cesar Aragon, MD         
Complejo Hospitalario Universitario de Santiago Recruiting
Santiago de Compostela, Spain, E-15706
Principal Investigator: Evaristo Varo, MD         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, E-41013
Principal Investigator: Jose-Miguel Cisneros, MD         
Hospital Universitario La Fe Recruiting
Valencia, Spain, E-46009
Principal Investigator: Marino Blanes, MD         
Sponsors and Collaborators
Grupo de Estudio de Infecciones en Transplantados
Merck Sharp & Dohme Corp.
Investigators
Study Director: Jesus Fortun, MD Hospital Ramon y Cajal, Madrid, Spain
More Information
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Publications of Results:
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].

ClinicalTrials.gov Identifier: NCT00333645     History of Changes
Other Study ID Numbers: GESITRA-01
03-0409 (Spanish Drug Agency)
First Posted: June 6, 2006    Key Record Dates
Last Update Posted: April 13, 2007
Last Verified: December 2006

Keywords provided by Grupo de Estudio de Infecciones en Transplantados:
Liver transplantation
Invasive fungal infection
Invasive aspergillosis
Prophylaxis
Caspofungin

Additional relevant MeSH terms:
Infection
Mycoses
Invasive Fungal Infections
Caspofungin
 Echinocandins
Antifungal Agents
Anti-Infective Agents