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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000804-17 | EudraCT Number |
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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The study is a randomized, open-label safety study comparing the use of anidulafungin (200 mg i.v. as initial dose and 100 mg/d i.v. in subsequent doses) vs liposomal amphotericin B (3 mg/kg/d i.v.) in hepatic transplant recipients who have high risk of fungal infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anidulafungin | Experimental | Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day. |
|
| Liposomal Amphotericin B | Active Comparator | Liposomal amphotericin B once a day: 3 mg/kg/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anidulafungin | Drug | Anidulafungin once a day for 14 days: initial dose 200 mg/day IV administered in 180 minutes. Following doses 100 mg/day IV administered in 90 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Renal impairment/renal function deterioration | Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B | 14 days |
| Number of infusion related adverse events | Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment discontinuation | Compare the proportion of patiens who discontinue antifungal profilaxis in both arms | 14 days |
| Hepatic toxicity | Compare the emergence of hepatic toxicity in both arms |
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Inclusion Criteria:
A: One of the following criteria (major criteria):
B: Two of the following criteria (minor criteria):
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Cervera, MD | Hospital Clinic i Provincial | Study Director |
| Asuncion Moreno, MD | Hospital Clinic i Provincial | Principal Investigator |
| Carmen Fariñas, MD | Hospital Marqués de Valdecilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sofia | Córdoba | Córdoba | Spain | |||
| Complexo Hospitalario de A Coruña |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D009181 | Mycoses |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077612 | Anidulafungin |
| C068538 | liposomal amphotericin B |
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Liposomal amphotericin B | Drug | Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes. |
|
|
| 14 days |
| Invasive fungal infection | Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms | Week 12 and week 24 |
| Mortality | Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation | 24 weeks post transplantation |
| A Coruña |
| Spain |
| Hospital Clinic i Provincial | Barcelona | Spain |
| Hospital de Bellvitge | Barcelona | Spain |
| Hospital Vall d'Hebrón | Barcelona | Spain |
| Hospital de Cruces | Bilbao | Spain |
| Hospital Doce de Octubre | Madrid | Spain |
| Hospital Gregorio Marañón | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Spain |
| Hospital Carlos Haya | Málaga | Spain |
| Hospital Central de Asturias | Oviedo | Spain |
| Hospital Marqués de Valdecilla | Santander | Spain |