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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

Mycoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00704951
• Other study ID #: P05532
• Status: Withdrawn
• Phase: N/A
• First received: June 23, 2008
• Last updated: August 24, 2015
• Start date: July 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: No HA approval required according to local law
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Immunocompromised patients with refractory IFI

• Patients eligible for prophylactic treatment due to anticipated neutropenia for more than 7 days.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mycoses

Intervention

Drug:
• Posaconazole or alternative fungal treatment
Dosage of Posaconazole: Prophylactic dosing: 200mg tid (600mg/day) Treatment dosing: 400mg bid (800mg/day)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: adverse events		Depending on treatment modality every 2 to 4 weeks	Yes
Secondary	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	No
Secondary	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	No
Secondary	Adverse events; Survival status		Depending on treatment modality every 2 to 4 weeks	Yes