Oral SCY-078 vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 80
Updated:6/10/2016
Start Date:September 2014
End Date:August 2016
Contact:David Angulo, MD
Email:info@scynexis.com
Phone:919-544-8697

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Open-Label, Randomized Study to Estimate Safety, PK, and Efficacy of Oral SCY-078 vs. Standard-of-Care Following IV Echinocandin Therapy in the Treatment of Invasive Candidiasis in Hospitalized Nonneutropenic Adults

The purpose of this study is to compare the safety, pharmacokinetics, and efficacy of oral
SCY-078 vs. standard-of-care following initial intravenous echinocandin therapy in the
treatment of invasive candidiasis.

Patients will receive initial intravenous (IV) echinocandin therapy. Patients who are
eligible for randomization will receive SCY-078 500-mg orally, SCY-078 750-mg orally, or
standard-of-care.

Inclusion Criteria:

- Diagnosis of invasive candidiasis defined as a positive culture of blood or from
another normally sterile site for Candida.

- Not of reproductive potential or if of reproductive potential, agrees to remain
abstinent or use 2 methods of contraception.

Exclusion Criteria:

- Patient with Candida endocarditis, osteomyelitis, meningitis, or chronic disseminated
candidiasis or evidence of endophthalmitis.

- Patient has failed treatment with an echinocandin for this episode of invasive
candidiasis.

- Infection limited to the oropharynx, esophagus, urogenital system, or skin, or
sputum/bronchoalveolar lavage culture.

- Participation in a clinical study with other investigational drug(s) within 30 days
prior to study entry or during this study.
We found this trial at
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Albany, New York 12208
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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Miami, Florida 33124
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
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Sacramento, California 95814
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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1120 15th Street
Augusta, Georgia 30912
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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733 North Broadway
Baltimore, Maryland 21205
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Butte, Montana 59701
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Chapel Hill, North Carolina 27599
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171 Ashley Avenue
Charleston, South Carolina 29425
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Dallas, Texas 75390
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4500 S. Lancaster Rd.
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1801 Inwood Rd
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Detroit, Michigan 48201
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2301 Erwin Rd
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
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164 Summit Ave
Providence, Rhode Island 02906
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Salt Lake City, Utah 84132
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