Protocol for therapeutic use of Posaconazolo out of clinical trials in patients with invasive resistant micosis and/or in tolerant patients. - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-004968-32-IT

Enrollment

100

Registered

2007-01-10

Start date

2006-09-07

Completion date

Unknown

Last updated

2021-10-26

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

Conditions

patients with invasive resistant micosis and/or tolerant patients MedDRA version: 6.1 Level: HLT Classification code 10003486

Interventions

Product Name: noxafil Pharmaceutical Form: Oral suspension Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -aspergillosis-fusariosis-cromoblastomicosis-coccidiomicosis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: -pregnancy and breastfeeding;-hypersensibility to azolic anti micotics; -subjects in treatment with vinca or antracicline 24 hours before posaconazolo treatment or subject requiring vinca or antracicline therapy for 30 days or more

Design outcomes

Primary

Measure	Time frame
Main Objective: to treat with posaconazolo adult patients affected by invasive micosis, intollerant or resistant to standard therapy;Secondary Objective: x;Primary end point(s): x	—

Countries

Italy

Outcome results

None listed

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