Liver Transplant European Study Into the Prevention of Fungal Infection

NCT01058174 ↗

Phase 3 Completed 350 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelPrevention

Summary

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

Timeline

Start: 2009-12-15
Primary completion: 2012-05-03
Completion: 2012-05-03

Outcome

Met primary endpoint

paper CONCLUSIONS: Micafungin was noninferior to standard care as antifungal prophylaxis in liver transplant patients at high risk for IFI. PMID 25520332 ↗

Publications

Saliba F, Pascher A, Cointault O, Laterre PF, Cervera C, De Waele JJ, Cillo U, Langer RM, Lugano M, Goran-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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Amphotericin B	Unknown	—	Intravenous
Comparator	Caspofungin	Other / unclassified	—	Intravenous
Comparator	Fluconazole	Small molecule	—	Intravenous
Subject	Micafungin	Peptide	100 mg	Intravenous