Secondary prophylaxis of invasive mycosis in immunocompromised patients by means of a weekly high dose of liposomal Amphotericin B - ND
- Conditions
- Invasive fungal infection in immunocompromised patientsMedDRA version: 8.1Level: LLTClassification code 10052366Term: Systemic mycosis
- Registration Number
- EUCTR2006-005030-20-IT
- Lead Sponsor
- ISTITUTO GIANNINA GASLINI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
1 invasive mycosis in an immunocompromised patient 2 clinical picture of the fungal infection stabilized, after at least 3 months of systemic treament 3 persistence of the condition that caused the impairment of the immune function 4 informed consent
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
severe adverse events related with the use of liposomal amphotericin B
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate safety of a weekly high dose of liposomal Amphotericin B;Secondary Objective: To evaluate efficacy of a weekly high dose of liposomal Amphotericin B as secondary prophylaxis of invasive mycosis in immunocompromised patients;Primary end point(s): To evaluate safety of a weekly high dose of liposomal Amphotericin B
- Secondary Outcome Measures
Name Time Method