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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01058174
Other study ID # 9463-EC-0001
Secondary ID 2008-005214-49
Status Completed
Phase Phase 3
First received
Last updated
Start date December 15, 2009
Est. completion date May 3, 2012

Study information

Verified date March 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prevention of invasive fungal infection in high risk patients following liver transplant.


Description:

After receiving liver transplant, subjects will be randomized to one of the two treatment arms.

Study drugs will be administered for a period of 21 days, or until hospital discharge, whichever occurs first.

Additionally, mortality data will be collected at the Long-term Follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date May 3, 2012
Est. primary completion date May 3, 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Undergoing orthotopic whole or split liver allograft transplantation

- Patients at 'high risk' of invasive fungal infection due to the presence of at least one of the following risk factors:

- Re-transplantation

- Acute liver failure

- Pre- or post-operative renal impairment (defined as creatinine clearance =40 ml/min) or need for renal replacement therapy

- Admission to Intensive Care Unit (ICU) for greater than 48 hours prior to liver transplant

- Re-operation (abdominal surgery) within 5 days of liver transplant

- Presence of choledocojejunostomy

- Perioperative colonization with fungi, defined as two or more positive clinical site surveillance cultures for Candida spp., obtained within 96 hours before or after liver transplant

- Need for prolonged mechanical ventilation for greater than 48 hours following liver transplant

- Transfusion intraoperatively of 20 or more units of cellular blood products

- Female subject of childbearing potential must have a negative urine or serum pregnancy test prior to randomization and must agree to maintain effective birth control during the study

Exclusion Criteria:

- Any systemic antifungal therapy (excluding fluconazole or oral nystatin for a maximum of 7 days) within 14 days prior to randomization

- Evidence of documented ('proven' or 'probable') or suspected ('possible') IFD (according to the EORTC/MSG criteria)

- Allergy, hypersensitivity, or any serious reaction to an echinocandin antifungal, or any of the study drugs or their excipients

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
micafungin
intravenous infusion
fluconazole
intravenous infusion
liposomal amphotericin B
intravenous infusion
caspofungin
intravenous infusion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Astellas Pharma Inc

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Hungary,  Ireland,  Italy,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). up to 21 days
Secondary Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB 3 months
Secondary Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator up to 21 days & 3 months
Secondary Time to 'proven' or 'probable' IFD up to 3 months
Secondary Fungal free survival at the End of Study and at the end of Long-term Follow-up 3 months & 6 months
Secondary Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline up to 21 days
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