Neutropenia (neutrophil count <500/mm3 for at least 10 days persistent fever for at least 72-96 hours, refrectory to the traetment with wide spectrum antibiotic appropriate for high risk patients MedDRA version: 9.1 Level: LLT Classification code 10029354 Term: Neutropenia
Conditions
Interventions
Trade Name: AMBISOME*INFUS 10FL LIOF 50MG
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Amphotericin B
CAS Number: 1397-89-3
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: . =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: AST- ALT more than 10 times the normal values of the age Bilirubina more than 5 times the normal values of the age Creatinina more than 3 times the normal values of the age Evidence of other infection batteric or viral documented evidence of invasive fungin infection in act o precedent previous randomization in the study in the last 3 month no consensus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to prove the utility of the empiric antifungin therapy in the treatment of the pediatric patient, neutropenic for antiblastic chemotherapy, low risk defined, with persistent fever after almost 96 hours of adequate empiric antibatteric therapy;Secondary Objective: 2. to prove non inferiority of one of both therapy (caspofungin and Amfotericina B liposomiale) in the empiric treatment of the feverly pazient, neutropenic for antiblastic chemotherapy 3. to verify the comparative profile of toxicity of the two therapy sperimented. in particular the renal and hepatic toxicity;Primary end point(s): persistence of the fever in the pazient of the controlled group in spite of those of every arm of treatment and to both two arms of treatment together | — |
Countries
Italy
Outcome results
None listed