Dettagli per singolo studio

DEC-NET Serial number IT485

Published online	22/09/2005 11.40.00
Last updated	12/01/2006 10.26.06

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	OTHER AND UNSPECIFIED MYCOSES
Experimental drug
Voriconazolo Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	0-18 years
Eligibility criteria
Inclusion criteria
- patients with immunodepression caused by drug therapy or with congenital immunodeficiency who have a probable or possible documented mycotic infection that is unresponsive to standard therapies or who have severe adverse reactions to standard antimycotic treatment (e.g. renal insufficiency, chills, fever, tremor, anaphylaxis, hepatotoxicity or neurotoxicity)
Exclusion criteria
- severe hepatic insufficiency defined as transaminase values more than 5 times the normal limit - personal case history of hypersensitivity reactions to triazoles or to echinocandins - concomitant use of barbiturates for patients who could be treated with voriconazole. In this case, a wash-out period of at least 2 weeks is required. - Lack of consent by the parents or legal representative or by the patient (if adolescent). Given the peculiarity of the clinical conditions of the patients who will be enrolled, a standard informed consent module is not foreseen, but this will be requested on an individual basis.
Trial design/methodology
Phase	2
Kind of study	Safety
Design
Purpose of study
Primary objective: - to assess the tolerability in patients less than 18 years old of new antifungal drugs in salvage therapy for probable or possible documented invasive mycoses that are refractory to treatment with 1) fluconazole at a dose of 15-20 mg/kg/day; 2) amphotericin B desoxycholate at a dose of 1-1.5 mg/kg/day; 3) amphotericin B lipid complex at a dose of 5 mg/kg/day; 4) voriconazole in patients aged less than 2 years old (depending on type of pathogen identified), administered for a minimum of 1-2 weeks, or that have presented serious adverse reactions caused by antimycotic therapy Secondary objective: - to assess the efficacy in terms of increased survival




Summary of study design, objectives, and ongoing research findings
The aim of this study is to assess the tolerability in patients less than 18 years old of new antifungal drugs in salvage therapy for probable or possible documented invasive mycoses that are not responsive to standard treatment or in whom standard treatment caused severe adverse reactions.