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Completed

NCT Number: NCT01303549

Anidulafungin vs Amphotericin B Safety in High Risk Hepatic Transplant Recipients

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.

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Key information

Conditions

Liver Disease Bacterial Infections and Mycoses Digestive System Diseases Fungal Infection Infections Liver Diseases Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Reina Sofia, Córdoba, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anidulafungin

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.

Other names: Ecalta

Liposomal Amphotericin B

Drug

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

Other names: AmBisome

Primary outcomes

  1. Renal impairment/renal function deterioration

    Time frame: 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

  2. Number of infusion related adverse events

    Time frame: 14 days

    Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B

Secondary outcomes

  1. Treatment discontinuation

    Time frame: 14 days

    Compare the proportion of patiens who discontinue antifungal profilaxis in both arms

  2. Hepatic toxicity

    Time frame: 14 days

    Compare the emergence of hepatic toxicity in both arms

  3. Invasive fungal infection

    Time frame: Week 12 and week 24

    Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms

  4. Mortality

    Time frame: 24 weeks post transplantation

    Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation

Sponsors and collaborators

Lead sponsor

Fundacion SEIMC-GESIDA

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: AVALTRA

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Feb 24, 2011
Registry last updated
May 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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