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

Sponsor

Fundacion SEIMC-GESIDA (Other)

Overall Status

Completed

CT.gov ID

NCT01303549

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arms

Duration (Months)

5.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Disease Fungal Infection	Drug: Anidulafungin Drug: Liposomal amphotericin B	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

May 1, 2014

Actual Study Completion Date :

May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Anidulafungin Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day.	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. Other Names: Ecalta
Active Comparator: Liposomal Amphotericin B Liposomal amphotericin B once a day: 3 mg/kg/day	Drug: Liposomal amphotericin B Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes. Other Names: AmBisome

Arm

Intervention/Treatment

Experimental: Anidulafungin

Anidulafungin IV once a day: initial dose 200 mg/day, following doses 100 mg/day.

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.

Other Names:

Ecalta

Active Comparator: Liposomal Amphotericin B

Liposomal amphotericin B once a day: 3 mg/kg/day

Drug: Liposomal amphotericin B

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

Other Names:

AmBisome

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Hospital Clinic i Provincial	Barcelona	Spain
2	Hospital de Bellvitge	Barcelona	Spain
3	Hospital Vall d'Hebrón	Barcelona	Spain
4	Hospital de Cruces	Bilbao	Spain
5	Hospital Reina Sofia	Córdoba	Spain
6	Complexo Hospitalario de A Coruña	La Coruña	Spain
7	Hospital Doce de Octubre	Madrid	Spain
8	Hospital Gregorio Marañón	Madrid	Spain
9	Hospital Ramón y Cajal	Madrid	Spain
10	Hospital Carlos Haya	Malaga	Spain
11	Hospital Central de Asturias	Oviedo	Spain
12	Hospital Marqués de Valdecilla	Santander	Spain