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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

NCT ID: NCT00704951

Last Updated: 2015-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Mycoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

Posaconazole or alternative fungal treatment

Intervention Type DRUG

Dosage of Posaconazole:

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

Interventions

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Posaconazole or alternative fungal treatment

Dosage of Posaconazole:

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P05532

Identifier Type: -

Identifier Source: org_study_id

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