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Secondary prophylaxis of invasive mycosis in immunocompromised patients by means of a weekly high dose of liposomal Amphotericin B - ND

Secondary prophylaxis of invasive mycosis in immunocompromised patients by means of a weekly high dose of liposomal Amphotericin B - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-005030-20-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 in immunocompromised patients MedDRA version: 8.1 Level: LLT Classification code 10052366 Term: Systemic mycosis

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: 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

Exclusion criteria: severe adverse events related with the use of liposomal amphotericin B

Design outcomes

Primary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

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