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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

This study has been withdrawn prior to recruitment.
Study NCT00704951.   Last updated on November 24, 2008.   Information provided by Schering-Plough

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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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)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Recruitment Status  Withdrawn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:

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

Exclusion Criteria:

  • None
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

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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