Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

Liver Disease Clinical Trial

— AVALTRA  

Official title:

Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01303549
• Other study ID #: GESITRA 0110
• Secondary ID: 2011-000804-17
• Status: Completed
• Phase: Phase 4
• First received: February 16, 2011
• Last updated: May 29, 2014
• Start date: November 2011
• Est. completion date: May 2014

Study information

• Verified date: September 2013
• Source: Fundacion SEIMC-GESIDA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fungal Infection
• Liver Disease
• Liver Diseases
• Mycoses

Intervention

Drug:
• Anidulafungin
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.
• Liposomal amphotericin B
Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.

Locations

Country	Name	City	State
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Hospital de Cruces	Bilbao
Spain	Hospital Reina Sofia	Córdoba
Spain	Complexo Hospitalario de A Coruña	La Coruña
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Gregorio Marañón	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Central de Asturias	Oviedo
Spain	Hospital Marqués de Valdecilla	Santander

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Treatment discontinuation	Compare the proportion of patiens who discontinue antifungal profilaxis in both arms	14 days	No
Secondary	Hepatic toxicity	Compare the emergence of hepatic toxicity in both arms	14 days	Yes
Secondary	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	Yes
Secondary	Mortality	Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation	24 weeks post transplantation	Yes