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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01303549
Other study ID # GESITRA 0110
Secondary ID 2011-000804-17
Status Completed
Phase Phase 4
First received February 16, 2011
Last updated May 29, 2014
Start date November 2011
Est. completion date May 2014

Study information

Verified date September 2013
Source Fundacion SEIMC-GESIDA
Contact n/a
Is FDA regulated No
Health authority Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
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

Sponsors (2)

Lead Sponsor Collaborator
Fundacion SEIMC-GESIDA Pfizer

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Renal impairment/renal function deterioration Compare the development of renal imparment or deterioration of baseline renal function in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B 14 days Yes
Primary Number of infusion related adverse events Compare the development of infusion related adverse events in hepatic transplat recipients who receive anidulafungin or liposomal amphotericin B 14 days Yes
Secondary Treatment discontinuation Compare the proportion of patiens who discontinue antifungal profilaxis in both arms 14 days No
Secondary Hepatic toxicity Compare the emergence of hepatic toxicity in both arms 14 days Yes
Secondary Invasive fungal infection Compare the incidence of early (first 12 weeks) and delayed (until week 24) invasive fungal infection between both arms Week 12 and week 24 Yes
Secondary Mortality Compare the mortality rate (both global and fungal infection related) between both arms 24 weeks after transplantation 24 weeks post transplantation Yes
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