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

Mycoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888197
• Other study ID #: CD101.TP.2.02
• Status: Completed
• Phase: N/A
• First received: August 30, 2016
• Last updated: February 28, 2018
• Start date: August 16, 2016
• Est. completion date: March 15, 2017

Study information

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

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 15, 2017
• Est. primary completion date: March 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	Olympian Clinical Research	Clearwater	Florida
United States	Women's Medical Research	Clearwater	Florida
United States	Women's Health Research	Columbus	Ohio
United States	Alliance Women's Research Group LLC	Delran	New Jersey
United States	Wayne State University	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	Tidwewater Physicians for Women	Norfolk	Virginia
United States	Drexel University	Philadelphia	Pennsylvania
United States	Precision Trials AZ	Phoenix	Arizona
United States	Soffolk OB/GYN	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	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	Rate of candida colonization	Rate of candida colonization	Up to Day 90 +/- 14 days
Secondary	Rate of recurrence of clinical signs/symptoms of VVC	Rate of recurrence of clinical signs/symptoms of VVC	Up to Day 90 +/- 14 days
Secondary	Time to recurrence of culture confirmed VVC	Time to recurrence of culture confirmed VVC	Up to Day 90 +/- 14 days
Secondary	Rates of recurrence of culture confirmed VVC	Rates of recurrence of culture confirmed VVC	Up to Day 90 +/- 14 days