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Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

NCT ID: NCT01303549

Last Updated: 2014-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Disease Fungal Infection

Keywords

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Liver transplantation Hepatic transplant Antifungal prophylaxis Anidulafungin Liposomal Amphotericin B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anidulafungin

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

Group Type EXPERIMENTAL

Anidulafungin

Intervention Type DRUG

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: 3 mg/kg/day

Group Type ACTIVE_COMPARATOR

Liposomal amphotericin B

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Liposomal amphotericin B

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

Intervention Type DRUG

Other Intervention Names

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Ecalta AmBisome

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Fundacion SEIMC-GESIDA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos Cervera, MD

Role: STUDY_DIRECTOR

Hospital Clinic i Provincial

Asuncion Moreno, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic i Provincial

Carmen Fariñas, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Marqués de Valdecilla

Locations

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Hospital Reina Sofia

Córdoba, Córdoba, Spain

Site Status

Complexo Hospitalario de A Coruña

A Coruña, , Spain

Site Status

Hospital Clinic i Provincial

Barcelona, , Spain

Site Status

Hospital de Bellvitge

Barcelona, , Spain

Site Status

Hospital Vall d'Hebrón

Barcelona, , Spain

Site Status

Hospital de Cruces

Bilbao, , Spain

Site Status

Hospital Doce de Octubre

Madrid, , Spain

Site Status

Hospital Gregorio Marañón

Madrid, , Spain

Site Status

Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Carlos Haya

Málaga, , Spain

Site Status

Hospital Central de Asturias

Oviedo, , Spain

Site Status

Hospital Marqués de Valdecilla

Santander, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2011-000804-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GESITRA 0110

Identifier Type: -

Identifier Source: org_study_id