Prophylaxis With Caspofungin in High-Risk Liver Transplantation

Study Overview
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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%.

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

Conditions
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Liver Transplantation, Fungal Infection

Intervention / Treatment
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* Drug: Caspofungin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Caspofungin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of breakthrough proven/probable invasive fungal infection by day +100 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver transplantation, Invasive fungal infection, Invasive aspergillosis, Prophylaxis, Caspofungin