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

Phase 2

Completed

Conditions: Candidiasis, Vulvovaginal
Mycoses
Yeast Infection
Moniliasis, Vulvovaginal
Vaginitis, Monilial

Interventions: Drug: CD101 Vaginal Gel (3%)
Drug: CD101 Vaginal Ointment (6%)
Drug: Fluconazole
Drug: CD101 External gel (1%)
Drug: CD101 External ointment (1%)

Registration Number: NCT02733432

Lead Sponsor: Cidara Therapeutics Inc.

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 126

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	CD101 Vaginal Gel (3%)	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.
Cohort 1	CD101 External gel (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.
Cohort 2	CD101 Vaginal Ointment (6%)	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.
Cohort 2	CD101 External ointment (1%)	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.
Cohort 3	Fluconazole	Oral fluconazole (150mg) administered on day 1.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in Vulvovaginal Scoring System	Day 28 - 35	Change in clinical signs and subject symptoms of VVC
Mycological Culture	Day 28 -35	Culture negative Candida

Trial Locations

Locations (24): Women's Medical Research
🇺🇸
Clearwater, Florida, United States
Augusta University
🇺🇸
Augusta, Georgia, United States
Seattle Women's Health, Research, Gynecology
🇺🇸
Seattle, Washington, United States
Women's Health Care Research Corp
🇺🇸
San Diego, California, United States
New Age Medical Research Corporation
🇺🇸
Miami, Florida, United States
Clinical Trials of Texas Inc
🇺🇸
San Antonio, Texas, United States
The Women's Clinical, P.A.
🇺🇸
Little Rock, Arkansas, United States
Aventiv Research Inc
🇺🇸
Columbus, Ohio, United States
Clinical Trials Management LLC
🇺🇸
Metairie, Louisiana, United States
Saginaw Valley Medical Research Group LLC
🇺🇸
Saginaw, Michigan, United States
TMC Life Research Inc.
🇺🇸
Houston, Texas, United States
Olympian Clinical Research
🇺🇸
Clearwater, Florida, United States
Precision Trials AZ LLC
🇺🇸
Phoenix, Arizona, United States
University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Tolan Park Clinic
🇺🇸
Detroit, Michigan, United States
Alliance Women's Research Group LLC
🇺🇸
Delran, New Jersey, United States
Hawthorne Medical Research Inc
🇺🇸
Winston-Salem, North Carolina, United States
Drexel University College of Medicine
🇺🇸
Philadelphia, Pennsylvania, United States
Tidewater Clinical Research, Inc
🇺🇸
Norfolk, Virginia, United States
ProHEALTH Care Associates, LLP
🇺🇸
Port Jefferson, New York, United States
Lawrence OB GYN Clinical Research LLC
🇺🇸
Lawrenceville, New Jersey, United States
Eastern Carolina Women's Center
🇺🇸
New Bern, North Carolina, United States
Unified Women's Clinical Research - Hickory
🇺🇸
Winston-Salem, North Carolina, United States
Altus Research Inc
🇺🇸
Lake Worth, Florida, United States