Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532) - Full Text View

Purpose

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.

Condition	Intervention
Mycoses	Drug: Posaconazole or alternative fungal treatment

MedlinePlus related topics:

Fungal Infections Molds

ChemIDplus related topics:

Posaconazole

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Safety: adverse events [ Time Frame: Depending on treatment modality every 2 to 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	August 2008
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Immunosuppressed/Immunocompromised patients at high risk for invasive fungal infections

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05532
First Received:	June 23, 2008
Last Updated:	August 12, 2008
ClinicalTrials.gov Identifier:	NCT00704951
Health Authority:	Austria: No HA approval required according to local law