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Completed

NCT Number: NCT02244606

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

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.

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Key information

Conditions

Mycoses Bacterial Infections and Mycoses Candidemia Candidiasis Candidiasis, Invasive Fungemia Infections Inflammation Invasive Fungal Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Militar Central, San Salvador, El Salvador

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCY-078

Drug

Fluconazole

Drug

Micafungin

Drug

Primary outcomes

  1. Safety and Tolerability, Assessed by Adverse Events, Clinical Laboratory Results, Physical Examination Findings, ECG Results, and Vital Sign Measurements

    Time frame: up to 10 weeks

    All Related TEAEs by SOC and PT, by Treatment, Safety

  2. Dose of SCY-078 That Achieves the Target Exposure (AUC)

    Time frame: 0 to 24 hours post-dose

    Summary of PK Parameters on Day 1 by Treatment Arm, from non-compartmental analysis, PK

Secondary outcomes

  1. Global Response

    Time frame: end of all antifungal therapy (administered for a maximum of 28 days)

    Participant's clinical response (signs or symptoms) and microbiological response (presence of Candida culture)

  2. Clinical Response

    Time frame: end of all antifungal therapy (administered for a maximum of 28 days)

    Participant's persistence of signs or symptoms and administration of systemic non-study antifungal therapy

  3. Microbiological Response

    Time frame: end of all antifungal therapy (administered for a maximum of 28 days)

    Cultures or radiographs/imaging of blood or non-blood sites of infection showing evidence of Candida infection

  4. Relapse

    Time frame: 2 weeks and 6 weeks after the end of all antifungal therapy, up to 10 weeks

    If Invasive Candida infection recurs or if antifungal therapy for a proven or suspected Candida infection is administered

Sponsors and collaborators

Lead sponsor

Scynexis, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 19, 2014
Registry last updated
Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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