Postoperative fungal infection. MedDRA version: 6.1 Level: PT Classification code 10052366
Conditions
Interventions
Trade Name: AMBISOME*INFUS 10FL LIOF 50MG
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Amphotericin B
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: adult patient undergoing orthotopic liver transplantation and high risk for postoperative fungal infection Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: renal function failure due to AmBL renal function failure of other causes Woman pregnant or breast feedinf
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the safety of liposomal amphotericin B at the dose of 10 mg/Kg a week for 3-4 weeks;Secondary Objective: The second end point is to evaluate the efficacy of this dose (10 mg/Kg a week) to prevent fungal infections in patients at high risk, meaning with one or two of the supra-mentioned conditions. A further end-point will be the compliance of patients and operators with this dosage.;Primary end point(s): safety of liposomal amphotericin B at the dose of 10 mg/Kg a week for 3-4 weeks | — |
Countries
Italy
Outcome results
None listed