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Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00034658
First Posted: May 2, 2002
Last Update Posted: March 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections:

A: which are refractory or resistant to standard antifungal therapies; B: for which there are currently no effective therapies; C: with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D: with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.


Condition Intervention Phase
Mycoses Drug: Posaconazole Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 336
Study Start Date: December 1998
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
Detailed Description:
The current clinical trial is designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections a)which are refractory or resistant to standard antifungal therapies or b) for which there are currently no effective therapies. Subjects with such invasive fungal infections cannot be enrolled in controlled, randomized clinical trials. Secondly, this clinical trial is also designed to provide posaconazole (SCH 56592) to subjects with invasive fungal infections who c) have experienced serious or severe toxicities while receiving standard antifungal therapies or d) have pre-existing organ dysfunction such as renal dysfunction who require standard antifungal therapy which is precluded because of the toxicities associated with such therapy. This clinical trial also serves to allow collection of preliminary data regarding the safety and efficacy of posaconazole (SCH 56592) against a variety of invasive fungal infections which although serious and life-threatening are sufficiently rare so that they cannot be studied in a controlled, randomized clinical trial.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Proven or probable invasive fungal infections according to EORTC/MSG criteria.
  • IFI are documented to be refractory to standard antifungal therapy OR intolerant to standard therapy.
  • Able to take oral medication or take medication via enteral feeding tube.

Exclusion Criteria

  • Concurrent progressive neurological disease (except if due to invasive fungal infection)
  • Use of medications that are known to interact with azoles and that may lead to life-threatening side to effects.
  • Prior enrollment in this study.
  • Subjects with a life expectancy of less than 72 hours.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
Study Data/Documents: CSR Synopsis  This link exits the ClinicalTrials.gov site

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034658     History of Changes
Other Study ID Numbers: P00041
First Submitted: May 1, 2002
First Posted: May 2, 2002
Last Update Posted: March 10, 2017
Last Verified: March 2017

Keywords provided by Merck Sharp & Dohme Corp.:
Aspergillosis, Candidiasis, Cryptococcosis,

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