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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

August 24, 2015 updated by: Merck Sharp & Dohme LLC

P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections
Drug: Posaconazole or alternative fungal treatment

Dosage of Posaconazole:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: adverse events
Time Frame: Depending on treatment modality every 2 to 4 weeks
Depending on treatment modality every 2 to 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Depending on treatment modality every 2 to 4 weeks
Depending on treatment modality every 2 to 4 weeks
Adverse events; Survival status
Time Frame: Depending on treatment modality every 2 to 4 weeks
Depending on treatment modality every 2 to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

June 23, 2008

First Submitted That Met QC Criteria

June 23, 2008

First Posted (Estimate)

June 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 24, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P05532

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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