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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007950-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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The aim of the study is to determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).
The prophylactic use of anti-fungal drugs is crucial in order to decrease the incidence of invasive fungal infections in transplantation patients.
Invasive fungal infections (IFI) ---organ-related or systemic infections--- are in fact one of the most important causes of morbidity and mortality in patients undergoing solid organ transplantation (respectively, 70% and 100%).
The rationale of the proposed study is to evaluate a new protocol for the prevention of IFIs through the use of a newly introduced anti-fungal, caspofungin (commercial name: Cancidas), to be used for primary prophylaxis of fungal infections post-OLTx and to compare to drugs already in use (eg. amphotericin B, fluconazole), until 21 days after liver transplantation.
The aim of this study is determine viable use of caspofungin in post-OLTx patients, and to demonstrate in particular the effectiveness, understood as the ability to reduce the incidence of invasive fungal infections, and to assess the ability to reduce the risk and incidence of side effects (toxicity) which may arise in transplant patients treated with other drugs, especially in individuals recognized as high risk (e.g. renal failure).
The possibility of reducing the risk of fungal infections in liver transplant patients (usually between 7 and 42%) is therefore an important clinical goal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caspofungin | Experimental | Study group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspofungin | Drug | 50mg/dd for 21dd, starting within 24h from Liver Transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Invasive Fungal Infection Free follow-up | Invasive Fungal Infection free control 1 month after beginning treatment. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance to treatment. | Tolerance to treatment, with major focus on nephrotoxicity. | 3 months |
| Study group mortality | Assessment of study group mortality, compared to control |
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Inclusion Criteria:
At least one of the following criteria:
Exclusion Criteria:
Subjects being removed from the trial shall be replaced.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Umberto Cillo, MD | Contact | +390498218624 | cillo@unipd.it | |
| Laura Saracino, MBS | Contact | +390498218624 | lasaracino@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Umberto Cillo, MD | Azienda Ospedaliera Universitaria di Padova | Principal Investigator |
| Daniele Neri, MD | Azienda Ospedaliera Universitaria di Padova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera di Padova | Recruiting | Padova | Padova | 35128 | Italy |
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| Label | URL |
|---|---|
| Hepatobiliary surgery and Liver Transplantation Unit, University Hospital of Padua (Italy) | View source |
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| ID | Term |
|---|---|
| D016469 | Fungemia |
| D009181 | Mycoses |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D018805 | Sepsis |
| D018746 | Systemic Inflammatory Response Syndrome |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| 3 months |
| Study group morbidity | Assessment of study group morbidity, compared to control | 3 months |
| Invasive Fungal Infection-free percentage of study group | Invasive Fungal Infection-free percentage of study group, evaluated at 1 month from beginning of study and assessment of mortality and morbidity in the control group | 1 month |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |