Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)
- Registration Number
- NCT00704951
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Immunocompromised patients with refractory IFI
- Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.
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Exclusion Criteria
- None
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients Posaconazole or alternative fungal treatment Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections
- Primary Outcome Measures
Name Time Method Safety: adverse events Depending on treatment modality every 2 to 4 weeks
- Secondary Outcome Measures
Name Time Method 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