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Clinical Trials/NCT00704951
NCT00704951WithdrawnNot Applicable

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

Merck Sharp & Dohme LLC0 sitesStarted: July 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Safety: adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

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)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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