Clinical trial NCT02733432: RADIANT: CD101 vs Standard of Care in Subjects With Acute Vaginal Yeast Infections
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Candidiasis, Vulvovaginal
Mycoses
Yeast Infection
Moniliasis, Vulvovaginal
Vaginitis, Monilial
Lead sponsor: Cidara Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
timeFrame: Day 28 - 35
Secondary outcomes:
measure: Change in Vulvovaginal Scoring System
timeFrame: Day 7 (+/- 2days)
measure: Change in Vulvovaginal Scoring System
timeFrame: Day 14 (+/- 2days)
measure: Change in Vulvovaginal Scoring System
timeFrame: Day 28 - 35
measure: Mycological Culture
timeFrame: Day 7 (+/- 2days)
measure: Mycological Culture
timeFrame: Day 14 (+/- 2days)
measure: Mycological Culture
timeFrame: Day 28 -35
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials AZ LLC
state: Arizona
city: Little Rock
country: United States
facility: The Women's Clinical, P.A.
state: Arkansas
city: San Diego
country: United States
facility: Women's Health Care Research Corp
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research Inc
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Detroit
country: United States
facility: Tolan Park Clinic
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group LLC
state: Michigan
city: Delran
country: United States
facility: Alliance Women's Research Group LLC
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OB GYN Clinical Research LLC
state: New Jersey
city: Port Jefferson
country: United States
facility: ProHEALTH Care Associates, LLP
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research - Hickory
state: North Carolina
city: Columbus
country: United States
facility: Aventiv Research Inc
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University College of Medicine
state: Pennsylvania
city: Houston
country: United States
facility: TMC Life Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: Norfolk
country: United States
facility: Tidewater Clinical Research, Inc
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology
state: Washington
Study officials:
affiliation: Cidara Therapeutics
name: Alena Jandourek, MD
role: STUDY_DIRECTOR
References: