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| Descriptive Information Fields | |
| Brief Title † | Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN) |
| Official Title † | P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007. |
| 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 | |
| Study Phase | |
| Study Type † | Observational |
| Study Design † | Cohort, Prospective |
| Primary Outcome Measure † | Safety: adverse events [ Time Frame: Depending on treatment modality every 2 to 4 weeks ] [ Designated as safety issue: Yes ] |
| Secondary Outcome Measure † | 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Adverse events; Survival status [ Time Frame: Depending on treatment modality every 2 to 4 weeks ] [ Designated as safety issue: Yes ] |
| Condition † | Mycoses |
| Intervention † | Drug: Posaconazole or alternative fungal treatment |
| MEDLINE PMIDs | |
| Links | |
| Recruitment Information Fields | |
| Recruitment Status † | Withdrawn |
| Enrollment † | 250 |
| Start Date † | July 2008 |
| Completion Date | June 2011 |
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | |
| Accepts Healthy Volunteers | No |
| Contacts †† | |
| Location Countries † | |
| Administrative Information Fields | |
| NCT ID † | NCT00704951 |
| Organization ID | P05532 |
| Secondary IDs †† | |
| Study Sponsor † | Schering-Plough |
| Collaborators †† | |
| Investigators † | |
| Information Provided By | Schering-Plough |
| Verification Date | November 2008 |
| First Received Date † | June 23, 2008 |
| Last Updated Date | November 24, 2008 |