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

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ClinicalTrials.gov Identifier: NCT02244606
Recruitment Status : Completed
First Posted : September 19, 2014
Last Update Posted : September 19, 2016
Sponsor:
Information provided by (Responsible Party):
Scynexis, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Mycoses Candidiasis, Invasive Candidemia Drug: SCY-078 Drug: Fluconazole Drug: Micafungin Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections

Arm Intervention/treatment
Experimental: SCY-078 500 mg
A single loading dose of SCY-078 1000-mg orally on the first day, followed by SCY-078 500-mg orally once-daily on subsequent days.
Drug: SCY-078
Experimental: SCY-078 750 mg
A single loading dose of SCY-078 1250-mg orally on the first day, followed by SCY-078 750-mg orally once-daily on subsequent days.
Drug: SCY-078
Active Comparator: Standard-of-care
Oral fluconazole 400 mg daily (with a loading dose of 800 mg on the first day) or IV micafungin 100 mg daily.
Drug: Fluconazole
Drug: Micafungin



Primary Outcome Measures :
  1. Safety and tolerability, assessed by adverse events, clinical laboratory results, physical examination findings, ECG results, and vital sign measurements [ Time Frame: from time of informed consent through 6-weeks after last study drug ]
  2. Dose of SCY-078 that achieves the target exposure (AUC) [ Time Frame: during randomized study drug (administered for a maximum of 23 days) ]

Secondary Outcome Measures :
  1. Global response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
  2. Clinical response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
  3. Microbiological response [ Time Frame: end of all antifungal therapy (administered for a maximum of 28 days) ]
  4. Relapse [ Time Frame: 2-weeks and 6-weeks after the end of all antifungal therapy ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02244606


  Show 30 Study Locations
Sponsors and Collaborators
Scynexis, Inc.
Investigators
Study Director: David Angulo, MD Scynexis, Inc.

Responsible Party: Scynexis, Inc.
ClinicalTrials.gov Identifier: NCT02244606     History of Changes
Other Study ID Numbers: SCY-078-202
First Posted: September 19, 2014    Key Record Dates
Last Update Posted: September 19, 2016
Last Verified: September 2016

Keywords provided by Scynexis, Inc.:
Invasive Candidiasis
Invasive Candida infections
Candidemia
SCY-078
Micafungin
Fluconazole
Echinocandin

Additional relevant MeSH terms:
Mycoses
Candidiasis
Candidemia
Candidiasis, Invasive
Fungemia
Sepsis
Infection
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fluconazole
Micafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors