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Nebulized liposomial Amphotericin B as rescue treatment of pulmonary and or sinusal invasive fungal infection - ND

Nebulized liposomial Amphotericin B as rescue treatment of pulmonary and or sinusal invasive fungal infection - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005031-21-IT
Enrollment
Unknown
Registered
2006-11-10
Start date
2007-02-16
Completion date
Unknown
Last updated
2012-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive fungal infection of the respiratory tract MedDRA version: 6.1 Level: HLT Classification code 10017537

Interventions

Trade Name: AMBISOME*INFUS 10FL LIOF 50MG Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Amphotericin B CAS Number: 1397-89-3 Concentration unit: mg milligram(s) Concentration type:

Sponsors

ISTITUTO GIANNINA GASLINI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Severe adverse events related with Nebulized liposomial Amphotericin B

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026