TENPIN: Liver Transplant European Study Into the Prevention of Fungal Infection

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01058174

Collaborator

(none)

350

Enrollment

Locations

Arms

28.6

Actual Duration (Months)

9.7

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Liver Transplantation Mycoses	Drug: micafungin Drug: fluconazole Drug: liposomal amphotericin B Drug: caspofungin	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Randomized, Open Label, Non-inferiority Study of Micafungin Versus Standard Care for the Prevention of Invasive Fungal Disease in High Risk Liver Transplant Recipients

Actual Study Start Date :

Dec 15, 2009

Actual Primary Completion Date :

May 3, 2012

Actual Study Completion Date :

May 3, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: micafungin intravenous infusion	Drug: micafungin intravenous infusion Other Names: Mycamine
Active Comparator: standard care intravenous infusion	Drug: fluconazole intravenous infusion Other Names: Diflucan Drug: liposomal amphotericin B intravenous infusion Other Names: AmBisome Drug: caspofungin intravenous infusion Other Names: Cancidas

Arm

Intervention/Treatment

Experimental: micafungin

intravenous infusion

Drug: micafungin

intravenous infusion

Other Names:

Mycamine

Active Comparator: standard care

intravenous infusion

Drug: fluconazole

intravenous infusion

Other Names:

Diflucan

Drug: liposomal amphotericin B

intravenous infusion

Other Names:

AmBisome

Drug: caspofungin

intravenous infusion

Other Names:

Cancidas

Outcome Measures

Primary Outcome Measures

'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [up to 21 days]

Secondary Outcome Measures

Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [3 months]
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]
Time to 'proven' or 'probable' IFD [up to 3 months]
Fungal free survival at the End of Study and at the end of Long-term Follow-up [3 months & 6 months]
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [up to 21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Innsbruck		Austria	6020
2	Antwerpen		Belgium	2650
3	Brussels		Belgium	1070
4	Brussels		Belgium	1200
5	Gent		Belgium	9000
6	Paris	Villejuif Cedex	France	94804
7	Clichy		France	32110
8	Paris		France	75013
9	Toulouse		France	31059
10	Berlin		Germany	13353
11	Hamburg		Germany	20246
12	Hannover		Germany	30625
13	Heidelberg		Germany	69120
14	Budapest		Hungary	1082
15	Dublin		Ireland	4
16	Milan		Italy	20146
17	Padova		Italy	35127
18	Torino		Italy	10126
19	Udine		Italy	33100
20	Coimbra		Portugal	3000-075
21	Porto		Portugal	4099-001
22	Bucharest		Romania	22328
23	Moscow		Russian Federation	123182
24	Moscow		Russian Federation	129090
25	St. Petersburg		Russian Federation	197758
26	Riyadh		Saudi Arabia
27	Santiago de Compostela	A Coruna	Spain	15706
28	Barakald	Vicaya	Spain	48903
29	Barcelona		Spain	08036
30	Cordoba		Spain	14004
31	Madrid		Spain	28007
32	Madrid		Spain	28034
33	Valencia		Spain	46009
34	Stockholm		Sweden	14186
35	Birmingham		United Kingdom	B15 2TH
36	London		United Kingdom	SE5 9RS