Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients (AVALTRA)

Fundacion SEIMC-GESIDA

Status and phase

Completed

Phase 4

Conditions

Fungal Infection

Liver Disease

Treatments

Drug: Liposomal amphotericin B

Drug: Anidulafungin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01303549

2011-000804-17 (EudraCT Number)

GESITRA 0110

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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