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Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

NCT01303549 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2014-05-30

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Liposomal amphotericin B

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Fundacion SEIMC-GESIDA

    lead OTHER

Principal Investigators

  • Carlos Cervera, MD · Hospital Clinic i Provincial

  • Asuncion Moreno, MD · Hospital Clinic i Provincial

  • Carmen Fariñas, MD · Hospital Marqués de Valdecilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-05-31
Completion
2014-05-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01303549 on ClinicalTrials.gov