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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
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 :	December 15, 2009
Actual Primary Completion Date :	May 3, 2012
Actual Study Completion Date :	May 3, 2012

Arms and Interventions

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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Absence of a 'proven' or 'probable' Invasive Fungal Disease (IFD) at the End of Study as assessed by the IDRB [ Time Frame: 3 months ]
2. 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 ]
3. Time to 'proven' or 'probable' IFD [ Time Frame: up to 3 months ]
4. Fungal free survival at the End of Study and at the end of Long-term Follow-up [ Time Frame: 3 months & 6 months ]
5. Incidence of superficial fungal infection and colonization at the End of Prophylaxis as compared to Baseline [ Time Frame: up to 21 days ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 36 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Director:	Use Central Contact	Astellas Pharma Europe Ltd.

More Information

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Additional Information:

Link to results on Astellas Clinical Study Results website 

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 ( EudraCT Number )
First Posted:	January 28, 2010
Last Update Posted:	November 22, 2017
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.
URL:	http://

Keywords provided by Astellas Pharma Inc:

Prophylaxis; Liver transplantation; Invasive Fungal Infection	Micafungin; Prevention; Mycoses

Additional relevant MeSH terms:

Mycoses; Fluconazole; Amphotericin B; Liposomal amphotericin B; Micafungin; Echinocandins; Caspofungin; Antifungal Agents; Anti-Infective 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; Amebicides; Antiprotozoal Agents; Antiparasitic Agents; Anti-Bacterial Agents