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 |
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.
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.
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
sites
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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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
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of Miami A private research university with more than 15,000 students from around the...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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4502 Medical Drive
San Antonio, Texas 78284
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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Georgia Regents University Georgia Regents University, home of the Medical College of Georgia, is one...
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Dallas VA Medical Center VA North Texas Health Care System (VANTHCS) is a progressive health...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Miriam Hospital The Miriam Hospital is a private, not-for-profit hospital, with a history of providing...
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