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
27
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1120 15th Street
Augusta, Georgia 30912
(706) 721-0211
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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
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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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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Albany, New York 12208
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
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Butte, Montana 59701
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Chapel Hill, North Carolina 27599
(919) 962-2211
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Dallas, Texas 75390
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4500 S. Lancaster Rd.
Dallas, Texas 75216
800-849-3597
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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Detroit, Michigan 48201
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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164 Summit Ave
Providence, Rhode Island 02906
(401) 793-2500
Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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Salt Lake City, Utah 84132
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San Antonio, Texas 78229
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San Salvador,
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St. Louis, Missouri 63108
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