NCT00034632

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 1, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2002

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

5.9 years

First QC Date

May 1, 2002

Last Update Submit

March 7, 2017

Conditions

Mycoses

Keywords

Aspergillosis, Candidiasis, Cryptococcosis, PhaeohyphomycosisInvasive Fungal Infections

Interventions

Posaconazole oral suspensionDRUG

Eligibility Criteria

Age13 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mezhir JJ, Mullane KM, Zarling J, Satoskar R, Pai RK, Roggin KK. Successful nonoperative management of gastrointestinal mucormycosis: novel therapy for invasive disease. Surg Infect (Larchmt). 2009 Oct;10(5):447-51. doi: 10.1089/sur.2008.049.

    PMID: 19485785RESULT

MeSH Terms

Conditions

MycosesAspergillosisCandidiasisCryptococcosisPhaeohyphomycosisInvasive Fungal Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2002

First Posted

May 2, 2002

Study Start

April 1, 2001

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 10, 2017

Record last verified: 2017-03