P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Merck Sharp & Dohme LLC
- Primary Endpoint
- Safety: adverse events
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Immunocompromised patients with refractory IFI
- •Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.
Exclusion Criteria
- Not provided
Arms & Interventions
Patients
Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections
Intervention: Posaconazole or alternative fungal treatment (Drug)
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(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)
