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

This study is currently recruiting participants.
Verified September 2013 by Fundacion SEIMC-GESIDA
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Fundacion SEIMC-GESIDA
ClinicalTrials.gov Identifier:
NCT01303549
First received: February 16, 2011
Last updated: September 11, 2013
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


Estimated Enrollment: 94
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01303549

Contacts
Contact: Miriam Ramírez, PhD +34915568025 mramirez@f-sg.org
Contact: Herminia Esteban, BSc +34915568025 hesteban@f-sg.org

Locations
Spain
Hospital Clinic i Provincial Recruiting
Barcelona, Spain
Principal Investigator: Carlos Cervera, MD         
Hospital Vall d'Hebrón Recruiting
Barcelona, Spain
Principal Investigator: Oscar Len, MD         
Hospital de Bellvitge Recruiting
Barcelona, Spain
Principal Investigator: Nuria Fernandez-Sabé, MD         
Hospital de Cruces Recruiting
Bilbao, Spain
Principal Investigator: Miguel Montejo, MD         
Hospital Reina Sofia Recruiting
Córdoba, Spain
Contact: Juan Carlos Pozo, MD         
Principal Investigator: Juan Carlos Pozo, MD         
Complexo Hospitalario de A Coruña Recruiting
La Coruña, Spain
Principal Investigator: Enrique Miguez Rey, MD         
Hospital Doce de Octubre Recruiting
Madrid, Spain
Principal Investigator: Carlos Lumbreras, MD         
Hospital Gregorio Marañón Recruiting
Madrid, Spain
Principal Investigator: Patricia Muñoz, MD         
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Principal Investigator: Jesús Fortún, MD         
Hospital Carlos Haya Recruiting
Malaga, Spain
Principal Investigator: César Aragón, MD         
Hospital Central de Asturias Recruiting
Oviedo, Spain
Principal Investigator: Manuel Rodríguez García, MD         
Hospital Marqués de Valdecilla Recruiting
Santander, Spain
Principal Investigator: Fernando Casfont, MD         
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: September 11, 2013
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
Liposomal amphotericin B
Anidulafungin
Echinocandins
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014