NCT00037206

Brief Summary

The combination of Anidulafungin plus AmBisome® may offer an improved outcome for patients treated for Invasive Aspergillosis (IA). The purpose of this study is to determine the safety and the clinical and microbiological effectiveness of anidulafungin plus AmBisome® in treated patients located in the United States, Europe, and South Africa.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2002

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2002

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2002

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
Last Updated

October 21, 2008

Status Verified

October 1, 2008

First QC Date

May 16, 2002

Last Update Submit

October 17, 2008

Conditions

Aspergillosis

Keywords

Invasive Aspergillosis

Interventions

Anidulafungin, VER002DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of definite IA outside the pulmonary system or definite or probable pulmonary IA
  • Life expectancy: greater than 72 hours

You may not qualify if:

  • Pregnant female
  • Hypersensitivity to anidulafungin or echinocandin therapy
  • Hypersensitivity to Tween 80 (polysorbate 80) or tartaric acid
  • Hypersensitivity to amphotericin B deoxycholate or any other constituents of AmBisome unless, in the opinion of the investigator, the benefit of therapy outweighs the risk.
  • Aspergilloma-in the absence of invasive disease
  • Abnormal blood chemistries:
  • Bilirubin \> 3 times the upper limit of normal; AST (aspartate aminotransferase) or ALT (alanine aminotransferase)\> 5 times the upper limit of normal
  • Greater than five days of therapeutic doses of systemic therapy for the current Aspergillus-associated condition or a cumulative dose of more than 5 mg/Kg of amphotericin, more than 25 mg/Kg of a lipid formulation of amphotericin, or more than 2g of itraconazole for the current condition. Prophylactic use of azoles or amphotericin is acceptable.
  • Less than 4 weeks since prior participation in an investigational drug or device study, with the exception of cytotoxic, antiretroviral agents and therapies for AIDS-related opportunistic infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Versicor, Inc.

King of Prussia, Pennsylvania, 19406, United States

Location

MeSH Terms

Conditions

Aspergillosis

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

EchinocandinsPeptides, CyclicPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 16, 2002

First Posted

May 17, 2002

Study Start

May 1, 2002

Study Completion

February 1, 2003

Last Updated

October 21, 2008

Record last verified: 2008-10

Locations

US(1)