Prospectic, multicentric, randomized, controlled trial for the evaluation of efficacy of Caspofungin vs Amfotericina B liposomiale for the empirical treatment of the FUO in children neutropenic for antiblastic chemotherapy - Caspofungin vs Ambisome

• Conditions: eutropenia (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: 9.1Level: LLTClassification code 10029354Term: Neutropenia

• Registration Number: EUCTR2006-001549-32-IT
• Lead Sponsor: A.I.E.O.P. - ASSOCIAZIONE ITALIANA EMATOLOGIA ONCOLOGIA PEDIATRICA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

. < 18 years . pazient with neoplasm, in antiblastic treatment with chemotherapy e/o CSE Transplantation . count of neutrophili < 500 mm3 . persistent fever (=38.0 ?c) after almost 96 hours of adequate empiric antibatteric therapy, applied as the recent protocol of any center
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified