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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00704951
First received: June 23, 2008
Last updated: November 24, 2008
Last verified: November 2008
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: P05532 Evaluation of Treatment and Prophylaxis of Invasive Fungal Infections (IFIs) in Immuncompromised Patients in Austria. Version 1, 08-Nov-2007.

Resource links provided by NLM:


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 ]

Estimated Enrollment: 250
Study Start Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00704951     History of Changes
Other Study ID Numbers: P05532
Study First Received: June 23, 2008
Last Updated: November 24, 2008
Health Authority: Austria: No HA approval required according to local law

Additional relevant MeSH terms:
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on July 24, 2014