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| ID | Type | Description | Link |
|---|---|---|---|
| 03-0409 (Spanish Drug Agency) |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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%.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspofungin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Absence of breakthrough proven/probable invasive fungal infection by day +100 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jesus Fortun, MD, PhD | Contact | +34-670-537460 | fortun@mi.madritel.es |
| Name | Affiliation | Role |
|---|---|---|
| Jesus Fortun, MD | Hospital Ramon y Cajal, Madrid, Spain | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Juan Canalejo | Recruiting | A Coruña | E-15006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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]. |
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| ID | Term |
|---|---|
| D009181 | Mycoses |
| D000072742 | Invasive Fungal Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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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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| Incidence of drug-related adverse event(s) |
| Hospital de Cruces | Recruiting | Barakaldo | E-48903 | Spain |
|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | E-08035 | Spain |
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| Complejo Hospitalario Reina Sofia | Withdrawn | Córdoba | E-14004 | Spain |
| Hospital Universitario Virgen de las Nieves | Recruiting | Granada | E-18014 | Spain |
|
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | E-28007 | Spain |
|
| Hospital Ramon y Cajal | Recruiting | Madrid | E-28034 | Spain |
|
| Hospital Universitario Puerta de Hierro | Recruiting | Madrid | E-28035 | Spain |
|
| Hospital 12 de Octubre | Recruiting | Madrid | E-28041 | Spain |
|
| Complejo Hospitalario Carlos Haya | Recruiting | Málaga | E-29010 | Spain |
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| Complejo Hospitalario Universitario de Santiago | Recruiting | Santiago de Compostela | E-15706 | Spain |
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| Hospital Universitario Virgen del Rocío | Recruiting | Seville | E-41013 | Spain |
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| Hospital Universitario La Fe | Recruiting | Valencia | E-46009 | Spain |
|
| D054714 |
| Echinocandins |
| D010456 | Peptides, Cyclic |