Clinical trial NCT01303549: Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Official title: Multicenter, Randomized, Open-label Clinical Trial to Compare Anidulafungin Versus Amphotericin B Safety in High Risk Hepatic Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Disease
Fungal Infection
Keywords: Liver transplantation
Hepatic transplant
Antifungal prophylaxis
Anidulafungin
Liposomal Amphotericin B
Lead sponsor: Fundacion SEIMC-GESIDA
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2011-02-24
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Renal impairment/renal function deterioration
timeFrame: 14 days
measure: Number of infusion related adverse events
timeFrame: 14 days
Secondary outcomes:
measure: Treatment discontinuation
timeFrame: 14 days
measure: Hepatic toxicity
timeFrame: 14 days
measure: Invasive fungal infection
timeFrame: Week 12 and week 24
measure: Mortality
timeFrame: 24 weeks post transplantation
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Córdoba
country: Spain
facility: Hospital Reina Sofia
city: La Coruña
country: Spain
facility: Complexo Hospitalario de A Coruña
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Oviedo
country: Spain
facility: Hospital Central de Asturias
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
Study officials:
affiliation: Hospital Clinic i Provincial
name: Carlos Cervera, MD
role: STUDY_DIRECTOR
affiliation: Hospital Clinic i Provincial
name: Asuncion Moreno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: Carmen Fariñas, MD
role: PRINCIPAL_INVESTIGATOR
References: