Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization

A Non-Interventional Extension Study to Investigate Vulvovaginal Candidiasis Recurrence and Candida Colonization Following a Phase 2 Randomized, Active-Controlled Study of Two Formulations of CD101 Compared to Fluconazole for the Treatment of Moderate to Severe Episodes of Acute Vulvovaginal Candidiasis

Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study

Study Overview

• Status: Completed
• Conditions: Mycoses; Candidiasis, Vulvovaginal; Yeast Infection; Moniliasis, Vulvovaginal; Vaginitis, Monilial

Detailed Description

Following completion of the 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 (NCT07299432), subjects without a recurrence of VVC will be followed up to an additional 90 days +/- 14 days to assess candida colonization and recurrence of VVC.

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • Precision Trials AZ
  • 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
      • Wayne State University
    • 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
      • Soffolk OB/GYN
  • 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
      • Women's Health Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
  • 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
      • Tidwewater Physicians for Women
  • 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

• Sampling Method: Non-Probability Sample

Study Population

Females previously enrolled in the primary study (NCT07299432) who had not been diagnosed with recurrence of vulvovaginal candidiasis and successfully completed the Day 28 visit in the primary study.

Description

Inclusion Criteria:

• Enrollment in and completed the primary study through the Day 28 visit.
• Received at least one dose of study drug in the primary study
• Able to give written informed consent prior to completion of the primary study

Exclusion Criteria:

• Received systemic or topical vaginal non-study antifungal therapy at any time during the primary study
• Diagnosed with bacterial vaginosis, trichomonas, gonorrhea, chlamydia, or active herpes at any point during the primary study
• The Principal Investigator considers that the subject should not participate in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recurrence of clinical signs/symptoms of VVC	Time to recurrence of clinical signs/symptoms of VVC	Up to Day 90 +/- 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of candida colonization	Rate of candida colonization	Up to Day 90 +/- 14 days
Rate of recurrence of clinical signs/symptoms of VVC	Rate of recurrence of clinical signs/symptoms of VVC	Up to Day 90 +/- 14 days
Time to recurrence of culture confirmed VVC	Time to recurrence of culture confirmed VVC	Up to Day 90 +/- 14 days
Rates of recurrence of culture confirmed VVC	Rates of recurrence of culture confirmed VVC	Up to Day 90 +/- 14 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 16, 2016
• Primary Completion (ACTUAL): March 15, 2017
• Study Completion (ACTUAL): March 15, 2017

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (ESTIMATE): September 2, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2018
• Last Update Submitted That Met QC Criteria: February 28, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Disease Attributes; Bacterial Infections and Mycoses; Vaginal Diseases; Vulvar Diseases; Vulvitis; Vulvovaginitis; Candidiasis; Recurrence; Mycoses; Vaginitis; Candidiasis, Vulvovaginal
• Other Study ID Numbers: CD101.TP.2.02

Plan for Individual participant data (IPD)

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