Liver Transplant European Study Into the Prevention of Fungal Infection - Full Text View

Purpose

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

Condition	Intervention	Phase
Liver Transplantation Mycoses	Drug: micafungin Drug: fluconazole Drug: liposomal amphotericin B Drug: caspofungin	Phase 3


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

Resource links provided by NLM:

MedlinePlus related topics: Fungal Infections Liver Transplantation Molds

Drug Information available for: Amphotericin B Fluconazole Caspofungin Caspofungin acetate Micafungin sodium Micafungin Liposomal Amphotericin B

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

'Clinical success' at the End of Prophylaxis as assessed by the Independent Data Review Board (IDRB). [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Absence of 'proven' or 'probable' IFD at the End of Prophylaxis and at the End of Study as assessed by the Investigator [ Time Frame: up to 21 days & 3 months ] [ Designated as safety issue: No ]
Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ] [ Designated as safety issue: No ]
Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ] [ Designated as safety issue: No ]


Enrollment:	350
Study Start Date:	December 2009
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: micafungin	Drug: micafungin intravenous infusion Other Name: Mycamine
Active Comparator: standard care	Drug: fluconazole intravenous infusion Other Name: Diflucan Drug: liposomal amphotericin B intravenous infusion Other Name: AmBisome Drug: caspofungin intravenous infusion Other Name: Cancidas

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

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: NCT01058174

Show 36 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators


Study Director:	Use Central Contact	Astellas Pharma Europe Ltd.

More Information

Additional Information:

Link to Results on JAPIC This link exits the ClinicalTrials.gov site

Link to results on Astellas Clinical Study Results website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Göran-Ericzon B, Phillips S, Tweddle L, Karas A, Brown M, Fischer L; TENPIN (Liver Transplant European Study Into the Prevention of Fungal Infection) Investigators; TENPIN Liver Transplant European Study Into the Prevention of Fungal Infection Investigators. Randomized trial of micafungin for the prevention of invasive fungal infection in high-risk liver transplant recipients. Clin Infect Dis. 2015 Apr 1;60(7):997-1006. doi: 10.1093/cid/ciu1128. Epub 2014 Dec 17.


Responsible Party:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT01058174 History of Changes
Other Study ID Numbers:	9463-EC-0001 2008-005214-49
Study First Received:	January 26, 2010
Last Updated:	June 5, 2015
Health Authority:	Austria: Federal Office for Safety in Health Care Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment Czech Republic: State Institute for Drug Control France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Hungary: National Institute of Pharmacy Ireland: Irish Medicines Board Italy: Ethics Committee Portugal: National Pharmacy and Medicines Institute Spain: Spanish Agency of Medicines United Kingdom: Medicines and Healthcare Products Regulatory Agency Russia: Ministry of Health of the Russian Federation Saudi Arabia: Ministry of Health Romania: National Medicines Agency Sweden: Medical Products Agency

Keywords provided by Astellas Pharma Inc:


Liver transplantation Prophylaxis Prevention	Mycoses Invasive Fungal Infection Micafungin

Additional relevant MeSH terms:


Mycoses Amphotericin B Liposomal amphotericin B Fluconazole Micafungin Echinocandins Caspofungin Amebicides Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Anti-Bacterial Agents	Antifungal Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP2C9 Inhibitors Cytochrome P-450 CYP2C19 Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016

Liver Transplant European Study Into the Prevention of Fungal Infection (TENPIN)