Back to resultsProphylaxis With Caspofungin in High-Risk Liver Transplantation
Primary Purpose
Liver Transplantation, Fungal Infection
Status
Unknown status
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Caspofungin
Sponsored by
About this trial
This is an interventional prevention trial for Liver Transplantation focused on measuring Liver transplantation, Invasive fungal infection, Invasive aspergillosis, Prophylaxis, Caspofungin
Eligibility 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.
Sites / Locations
- Hospital de CrucesRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Complejo Hospitalario Reina Sofia
- Hospital Universitario Virgen de las NievesRecruiting
- Complejo Hospitalario Juan CanalejoRecruiting
- Hospital General Universitario Gregorio MarañónRecruiting
- Hospital Ramon y CajalRecruiting
- Hospital Universitario Puerta de HierroRecruiting
- Hospital 12 de OctubreRecruiting
- Complejo Hospitalario Carlos HayaRecruiting
- Complejo Hospitalario Universitario de SantiagoRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Universitario La FeRecruiting
Outcomes
Primary Outcome Measures
Absence of breakthrough proven/probable invasive fungal infection by day +100
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00333645
First Posted
June 4, 2006
Last Updated
April 12, 2007
Sponsor
Grupo de Estudio de Infecciones en Transplantados
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00333645
Brief Title
Prophylaxis With Caspofungin in High-Risk Liver Transplantation
Official Title
Prophylaxis With Caspofungin for the Prevention of Invasive Fungal Infections in High-Risk Liver Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Grupo de Estudio de Infecciones en Transplantados
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Transplantation, Fungal Infection
Keywords
Liver transplantation, Invasive fungal infection, Invasive aspergillosis, Prophylaxis, Caspofungin
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Caspofungin
Primary Outcome Measure Information:
Title
Absence of breakthrough proven/probable invasive fungal infection by day +100
Secondary Outcome Measure Information:
Title
Absence of breakthrough proven/probable invasive aspergillosis by day +100
Title
Discontinuation of study therapy due to a drug-related adverse event
Title
Incidence of drug-related serious adverse event(s)
Title
Incidence of drug-related adverse event(s)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus Fortun, MD, PhD
Phone
+34-670-537460
Email
fortun@mi.madritel.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesus Fortun, MD
Organizational Affiliation
Hospital Ramon y Cajal, Madrid, Spain
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Cruces
City
Barakaldo
ZIP/Postal Code
E-48903
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Montejo, MD
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
E-08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Gavaldà, MD
Facility Name
Complejo Hospitalario Reina Sofia
City
Cordoba
ZIP/Postal Code
E-14004
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Hospital Universitario Virgen de las Nieves
City
Granada
ZIP/Postal Code
E-18014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Garrote, MD
Facility Name
Complejo Hospitalario Juan Canalejo
City
La Coruña
ZIP/Postal Code
E-15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro Llinares, MD
Facility Name
Hospital General Universitario Gregorio Marañón
City
Madrid
ZIP/Postal Code
E-28007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Muñoz, MD
Facility Name
Hospital Ramon y Cajal
City
Madrid
ZIP/Postal Code
E-28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Fortun, MD
Facility Name
Hospital Universitario Puerta de Hierro
City
Madrid
ZIP/Postal Code
E-28035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Ramos, MD
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
E-28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael San Juan, MD
Facility Name
Complejo Hospitalario Carlos Haya
City
Malaga
ZIP/Postal Code
E-29010
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cesar Aragon, MD
Facility Name
Complejo Hospitalario Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
E-15706
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evaristo Varo, MD
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
E-41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose-Miguel Cisneros, MD
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
E-46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marino Blanes, MD
12. IPD Sharing Statement
Citations:
Citation
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].
Results Reference
result
Learn more about this trial
Prophylaxis With Caspofungin in High-Risk Liver Transplantation
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