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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01303549
First received: February 16, 2011
Last updated: May 29, 2014
Last verified: September 2013
  Purpose

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 Intervention Phase
Liver Disease
Fungal Infection
Drug: Anidulafungin
Drug: Liposomal amphotericin B
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fundacion SEIMC-GESIDA:

Primary Outcome Measures:
  • Renal impairment/renal function deterioration [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B


Secondary Outcome Measures:
  • Treatment discontinuation [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Compare the proportion of patiens who discontinue antifungal profilaxis in both arms

  • Hepatic toxicity [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Compare the emergence of hepatic toxicity in both arms

  • Invasive fungal infection [ Time Frame: Week 12 and week 24 ] [ Designated as safety issue: Yes ]
    Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms

  • Mortality [ Time Frame: 24 weeks post transplantation ] [ Designated as safety issue: Yes ]
    Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation


Enrollment: 61
Study Start Date: November 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: AmBisome

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303549

Locations
Spain
Hospital Clinic i Provincial
Barcelona, Spain
Hospital de Bellvitge
Barcelona, Spain
Hospital Vall d'Hebrón
Barcelona, Spain
Hospital de Cruces
Bilbao, Spain
Hospital Reina Sofia
Córdoba, Spain
Complexo Hospitalario de A Coruña
La Coruña, Spain
Hospital Doce de Octubre
Madrid, Spain
Hospital Gregorio Marañón
Madrid, Spain
Hospital Ramón y Cajal
Madrid, Spain
Hospital Carlos Haya
Malaga, Spain
Hospital Central de Asturias
Oviedo, Spain
Hospital Marqués de Valdecilla
Santander, Spain
Sponsors and Collaborators
Fundacion SEIMC-GESIDA
Pfizer
Investigators
Study Director: Carlos Cervera, MD Hospital Clinic i Provincial
Principal Investigator: Asuncion Moreno, MD Hospital Clinic i Provincial
Principal Investigator: Carmen Fariñas, MD Hospital Marqués de Valdecilla
  More Information

No publications provided

Responsible Party: Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier: NCT01303549     History of Changes
Other Study ID Numbers: GESITRA 0110, 2011-000804-17
Study First Received: February 16, 2011
Last Updated: May 29, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundacion SEIMC-GESIDA:
Liver transplantation
Hepatic transplant
Antifungal prophylaxis
Anidulafungin
Liposomal Amphotericin B

Additional relevant MeSH terms:
Liver Diseases
Mycoses
Digestive System Diseases
Amphotericin B
Anidulafungin
Echinocandins
Liposomal amphotericin B
Amebicides
Anti-Bacterial Agents
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014