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

Mycoses Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733432
• Other study ID #: CD101.TP.2.01
• Status: Completed
• Phase: Phase 2
• Start date: June 8, 2016
• Est. completion date: December 23, 2016

Study information

• Verified date: March 2018
• Source: Cidara Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: December 23, 2016
• Est. primary completion date: November 23, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Vulvovaginal
• Infection
• Moniliasis, Vulvovaginal
• Mycoses
• Vaginitis
• Vaginitis, Monilial
• Yeast Infection

Intervention

Drug:
• CD101 Vaginal Gel (3%)
CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
• CD101 External gel (1%)
CD101 external gel (1%) applied topically twice daily over 72 hours as needed
• CD101 Vaginal Ointment (6%)
CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
• CD101 External ointment (1%)
CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
• Fluconazole
oral fluconazole (150mg) on Day 1

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cidara Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

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