Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
- Conditions
- Liver DiseaseFungal Infection
- Interventions
- Registration Number
- NCT01303549
- Lead Sponsor
- Fundacion SEIMC-GESIDA
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- At least 18 years old
- Signature of ICF
- Negative pregnancy test (women of child bearing potential)
- Patients who comply with at least one of the following (A or B):
A: One of the following criteria (major criteria):
- Re-transplant due to severe dysfunction of a previous hepatic graft
- Requirement of any renal substitutive therapy, including dialysis or hemofiltration
- Fulminant hepatitis requiring hepatic transplant
B: Two of the following criteria (minor criteria):
- Post-transplant renal impairment (defined as CrCl< 50 mL/min) 30 days after transplantation
- Intra surgery blood transfusion of at least 40 units
- Choledochal jejunectomy
- 2 or more Candida sp cultures (nasal, pharynx, rectal) from 48 hours pre- to 48 hours post-hepatic transplant
- Post transplant re-intervention (laparotomy)
- Hypersensibility to amphotericin B or candin
- Patients who have received any other antifungal (excluding fluconazole or oral nystatin for a maximum of 7 days)
- Documented or suspected fungal infection
- Pregnant women of women who do not accept to us a valid anticonceptive method
- Any other disease or medical condition that makes the patient not adequate to participate in the trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anidulafungin Anidulafungin Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day. Liposomal Amphotericin B Liposomal amphotericin B Liposomal amphotericin B once a day: 3 mg/kg/day
- Primary Outcome Measures
Name Time Method Renal impairment/renal function deterioration 14 days Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
Number of infusion related adverse events 14 days Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B
- Secondary Outcome Measures
Name Time Method Treatment discontinuation 14 days Compare the proportion of patiens who discontinue antifungal profilaxis in both arms
Hepatic toxicity 14 days Compare the emergence of hepatic toxicity in both arms
Invasive fungal infection Week 12 and week 24 Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms
Mortality 24 weeks post transplantation Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation
Trial Locations
- Locations (12)
Hospital de Bellvitge
🇪🇸Barcelona, Spain
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Clinic i Provincial
🇪🇸Barcelona, Spain
Hospital Carlos Haya
🇪🇸Malaga, Spain
Hospital Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital de Cruces
🇪🇸Bilbao, Spain
Complexo Hospitalario de A Coruña
🇪🇸La Coruña, Spain
Hospital Reina Sofia
🇪🇸Córdoba, Spain
Hospital Doce de Octubre
🇪🇸Madrid, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Gregorio Marañón
🇪🇸Madrid, Spain
Hospital Central de Asturias
🇪🇸Oviedo, Spain