Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00704951

Enrollment

Registered

2008-06-25

Start date

2008-07-31

Completion date

2011-06-30

Last updated

2015-08-25

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

Conditions

Mycoses

Brief summary

The purpose of this program is to determine the frequency of the use of Posaconazole in immunocompromised patients refractory to first line therapy receiving therapeutic treatment based on different pathogens in comparison to other antifungal therapy. A further objective is to determine the frequency of the use of Posaconazole in immunocompromised patients receiving prophylactic treatment in comparison to other antifungal prophylaxis.

Interventions

DRUGPosaconazole or alternative fungal treatment

Dosage of Posaconazole: Prophylactic dosing: 200mg tid (600mg/day) Treatment dosing: 400mg bid (800mg/day)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Immunocompromised patients with refractory IFI * Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame
Safety: adverse events	Depending on treatment modality every 2 to 4 weeks

Secondary

Measure	Time frame
Baseline: Patient demographic data; Disease history; Underlying diseases; Diagnosis; Previous therapies; Environmental risk factors; Host factors Performance status	Depending on treatment modality every 2 to 4 weeks
Treatment and follow up period: Performance status; Medication; Duration of treatment; Frequency of infectious episodes; Management of infections	Depending on treatment modality every 2 to 4 weeks
Adverse events; Survival status	Depending on treatment modality every 2 to 4 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026