Fungal Infection, Liver Disease
Conditions
Keywords
Liver transplantation, Hepatic transplant, Antifungal prophylaxis, Anidulafungin, Liposomal Amphotericin B
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.
Interventions
DRUGAnidulafungin
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.
DRUGLiposomal amphotericin B
Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.
Sponsors
Pfizer
Fundacion SEIMC-GESIDA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed