Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundacion SEIMC-GESIDA
• Collaborator: Pfizer
• Treatments: Amphotericin B; Anidulafungin; Echinocandins; Liposomal amphotericin B

Criteria

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