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

August 21, 2020 updated by: Cidara Therapeutics Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
126

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects with Incidence of Treatment Emergent Adverse Events [Safety and Tolerability]
Time Frame: Day 28 - 35
adverse events, clinical chemistry and hematology, pelvic exams
Day 28 - 35

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Vulvovaginal Scoring System
Time Frame: Day 7 (+/- 2days)
Change in clinical signs and subject symptoms of VVC
Day 7 (+/- 2days)
Change in Vulvovaginal Scoring System
Time Frame: Day 14 (+/- 2days)
Change in clinical signs and subject symptoms of VVC
Day 14 (+/- 2days)
Change in Vulvovaginal Scoring System
Time Frame: Day 28 - 35
Change in clinical signs and subject symptoms of VVC
Day 28 - 35
Mycological Culture
Time Frame: Day 7 (+/- 2days)
Culture negative for Candida
Day 7 (+/- 2days)
Mycological Culture
Time Frame: Day 14 (+/- 2days)
Culture negative Candida
Day 14 (+/- 2days)
Mycological Culture
Time Frame: Day 28 -35
Culture negative Candida
Day 28 -35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cidara Therapeutics Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alena Jandourek, MD, Cidara Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 8, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 23, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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