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Open Label Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P00041)(COMPLETED)
This study has been completed.
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00034658
  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 III

MedlinePlus related topics: Fungal Infections Molds
Drug Information available for: Posaconazole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Open Label, Treatment Protocol for the Safety and Efficacy of Posaconazole (SCH 56592) in the Treatment of Invasive Fungal Infections

Further study details as provided by Schering-Plough:

Estimated Enrollment: 337
Study Start Date: January 1999
Estimated Study Completion Date: September 2001
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

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
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

Study ID Numbers: P00041
Study First Received: May 1, 2002
Last Updated: May 31, 2006
ClinicalTrials.gov Identifier: NCT00034658  
Health Authority: United States: Food and Drug Administration

Keywords provided by Schering-Plough:
Aspergillosis, Candidiasis, Cryptococcosis,

Study placed in the following topic categories:
Mycoses
Candidiasis
Clotrimazole
Miconazole
Tioconazole
Aspergillosis
Posaconazole
Cryptococcosis

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

ClinicalTrials.gov processed this record on January 16, 2009