RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections

A Phase 2, Multicenter, Randomized, Active-controlled Study of the Safety and Tolerability of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

The purpose of this study is to determine if two topical formulations of CD101 are safe and effective in the treatment of acute moderate to severe vulvovaginal candidiasis (VVC) compared to oral fluconazole.

Study Overview

• Status: Completed
• Conditions: Mycoses; Candidiasis, Vulvovaginal; Yeast Infection; Moniliasis, Vulvovaginal; Vaginitis, Monilial
• Intervention / Treatment: Drug: CD101 Vaginal Gel (3%); Drug: CD101 External gel (1%); Drug: CD101 Vaginal Ointment (6%); Drug: CD101 External ointment (1%); Drug: Fluconazole

Detailed Description

This is a Phase 2, multicenter, randomized, open-label, sponsor-blind, active-controlled, dose-ranging trial of female subjects with an acute moderate to severe episode of vulvovaginal candidiasis. Subjects will be randomized to 1 of 3 treatment arms; CD101 gel, CD101 ointment, or oral fluconazole. After randomization, subjects will be seen on Day 7 (+/-2 days), Day 14 (+/- 2 days), & Day 28 (+/-7 days) to assess therapeutic cure and safety.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ LLC
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • The Women's Clinical, P.A.
  • California
    • San Diego, California, United States, 92111
      • Women's Health Care Research Corp
  • Florida
    • Clearwater, Florida, United States, 33756
      • Olympian Clinical Research
    • Clearwater, Florida, United States, 33759
      • Women's Medical Research
    • Lake Worth, Florida, United States, 33461
      • Altus Research Inc
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management LLC
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Tolan Park Clinic
    • Saginaw, Michigan, United States, 48604
      • Saginaw Valley Medical Research Group LLC
  • New Jersey
    • Delran, New Jersey, United States, 08075
      • Alliance Women's Research Group LLC
    • Lawrenceville, New Jersey, United States, 08648
      • Lawrence OB GYN Clinical Research LLC
  • New York
    • Port Jefferson, New York, United States, 11777
      • ProHEALTH Care Associates, LLP
  • North Carolina
    • New Bern, North Carolina, United States, 28562
      • Eastern Carolina Women's Center
    • Winston-Salem, North Carolina, United States, 27103
      • Hawthorne Medical Research Inc
    • Winston-Salem, North Carolina, United States, 27103
      • Unified Women's Clinical Research - Hickory
  • Ohio
    • Columbus, Ohio, United States, 43123
      • Aventiv Research Inc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University College of Medicine
  • Texas
    • Houston, Texas, United States, 77054
      • TMC Life Research Inc.
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas Inc
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Tidewater Clinical Research, Inc
  • Washington
    • Seattle, Washington, United States, 98105
      • Seattle Women's Health, Research, Gynecology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• moderate to severe acute vulvovaginal candidiasis (severity score >7)
• positive potassium hydroxide wet preparation for pseudohyphae or budding yeast or positive Becton Dickinson Affirm test or positive vaginal culture for Candida species
• vaginal pH <4.5 for subjects with positive potassium hydroxide wet preparation
• able to give written informed consent

Exclusion Criteria:

• receipt of intravaginal or systemic antifungal therapy within 7 days of randomization
• known or suspected infectious causes of vulvovaginitis other than candidiasis
• history of genital herpes
• planned treatment or surgery during the study period for cervical intraepithelial neoplasia or cervical carcinoma
• need for non-protocol systemic or vaginal antifungal therapy
• history of hypersensitivity or allergic reaction to echinocandins, azoles, or their excipients
• pregnant females
• females who are breast feeding
• women intending to become pregnant during the study period
• recent use of an investigational medicinal product within 28 days or presence of an investigational device at the time of screening
• subjects who use or anticipate use of intravaginal products
• have any condition that the Investigator believes would put the subject at risk for participation or would confound the results of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; CD101 Vaginal Gel (3%) topically self-administered intravaginally as a single dose on days 1 and 2 and for symptomatic relief CD101 External Gel (1%)topically self-applied to external vulva up to twice per day over 72 hours.	Drug: CD101 Vaginal Gel (3%); CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2; Drug: CD101 External gel (1%); CD101 external gel (1%) applied topically twice daily over 72 hours as needed
EXPERIMENTAL: Cohort 2; CD101 Vaginal Ointment (6%) topically self-administered intravaginally as a single dose on day 1 and for symptomatic relief CD101 External Ointment (1%) topically self-applied to external vulva up to twice per day over 72 hours.	Drug: CD101 Vaginal Ointment (6%); CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1; Drug: CD101 External ointment (1%); CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
ACTIVE_COMPARATOR: Cohort 3; Oral fluconazole (150mg) administered on day 1.	Drug: Fluconazole; oral fluconazole (150mg) on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]	adverse events, clinical chemistry and hematology, pelvic exams	Day 28 - 35

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Vulvovaginal Scoring System	Change in clinical signs and subject symptoms of VVC	Day 7 (+/- 2days)
Change in Vulvovaginal Scoring System	Change in clinical signs and subject symptoms of VVC	Day 14 (+/- 2days)
Change in Vulvovaginal Scoring System	Change in clinical signs and subject symptoms of VVC	Day 28 - 35
Mycological Culture	Culture negative for Candida	Day 7 (+/- 2days)
Mycological Culture	Culture negative Candida	Day 14 (+/- 2days)
Mycological Culture	Culture negative Candida	Day 28 -35

Collaborators and Investigators

• Sponsor: Cidara Therapeutics Inc.
• Investigators: Study Director: Alena Jandourek, MD, Cidara Therapeutics

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2016
• Primary Completion (ACTUAL): November 23, 2016
• Study Completion (ACTUAL): December 23, 2016

Study Registration Dates

• First Submitted: March 28, 2016
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (ESTIMATE): April 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 21, 2020
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Vaginal Diseases; Vulvar Diseases; Vulvitis; Vulvovaginitis; Infections; Candidiasis; Mycoses; Vaginitis; Candidiasis, Vulvovaginal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Fluconazole; Rezafungin
• Other Study ID Numbers: CD101.TP.2.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No