Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00034632
First received: May 1, 2002
Last updated: September 30, 2014
Last verified: September 2014
  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 oral suspension
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.:

Study Start Date: April 2001
Study Completion Date: March 2007
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.

This is an open-label, treatment protocol for a multi-center study of posaconazole (SCH 56592) 200mg orally four times daily (QID) while hospitalized followed by posaconazole (SCH 56592) 400mg orally twice daily (BID) on discharge from hospital, in the treatment of invasive fungal infections. Approximately 320 subjects have been enrolled at 160 clinical study centers in the US and worldwide.

  Eligibility

Ages Eligible for Study:   13 Years to 65 Years
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:

  • History of serious or severe hypersensitivity or idiosyncratic reactions to azole antifungals.
  • 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 effects: terfenadine, cisapride, ebastine at entry or within 24 hours prior to therapy, or astemizole at entry or within 10 days prior to entry.concentration/efficacy of azole antifungals: rifampin, carbamazepine.
  • Females pregnant or nursing.
  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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00034632     History of Changes
Other Study ID Numbers: P02095
Study First Received: May 1, 2002
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Aspergillosis, Candidiasis, Cryptococcosis, Phaeohyphomycosis
Invasive Fungal Infections

Additional relevant MeSH terms:
Infection
Mycoses
Posaconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Trypanocidal Agents

ClinicalTrials.gov processed this record on October 22, 2014