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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

Merck Sharp & Dohme LLC

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Mycoses

Interventions

Posaconazole or alternative fungal treatmentDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Immunocompromised patients with refractory IFI * Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days. Exclusion Criteria: * None

Outcomes

Primary Outcomes

Safety: adverse events

Time frame: Depending on treatment modality every 2 to 4 weeks

Secondary Outcomes

Baseline: Patient demographic data; Disease history; Underlying diseases; Diagnosis; Previous therapies; Environmental risk factors; Host factors Performance status

Time frame: 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

Time frame: Depending on treatment modality every 2 to 4 weeks

Adverse events; Survival status

Time frame: Depending on treatment modality every 2 to 4 weeks

Data from ClinicalTrials.gov

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