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of Treatment and Prophylaxis of Invasive Fungal Infections in Immuncompromised Patients in Austria (Study P05532)(WITHDRAWN)

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ClinicalTrials.gov Identifier: NCT00704951
Recruitment Status : Withdrawn
First Posted : June 25, 2008
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.


Condition or disease Intervention/treatment
Mycoses Drug: Posaconazole or alternative fungal treatment

Study Type : Observational
Actual Enrollment : 0 participants
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.
Study Start Date : July 2008
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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)




Primary Outcome Measures :
  1. Safety: adverse events [ Time Frame: Depending on treatment modality every 2 to 4 weeks ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Adverse events; Survival status [ Time Frame: Depending on treatment modality every 2 to 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00704951     History of Changes
Other Study ID Numbers: P05532
First Posted: June 25, 2008    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Mycoses
Invasive Fungal Infections
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs