ebulized liposomial Amphotericin B as rescue treatment of pulmonary and or sinusal invasive fungal infection - ND
- Conditions
- Invasive fungal infection of the respiratory tractMedDRA version: 6.1Level: HLTClassification code 10017537
- Registration Number
- EUCTR2006-005031-21-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
Invasive pulmonary or sinusal mycosis in a patient with Hemato-Oncologic disease 1 Worsening of clinical condition after at least seven days of systemic antifungal therapy or 2 Severe adverse events related with systemic antifungal drugs 3 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 Nebulized liposomial 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 Nebulized liposomial Amphotericin B;Secondary Objective: To evaluate efficacy of Nebulized liposomial Amphotericin B;Primary end point(s): To evaluate safety of Nebulized liposomial Amphotericin B
- Secondary Outcome Measures
Name Time Method