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

Completed

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

• Registration Number: NCT02888197
• Lead Sponsor: Cidara Therapeutics Inc.

Brief Summary

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

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 Timeline

• Study Start: 2016-08-16
• Study First Submitted: 2016-08-30
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-02
• Primary Completion: 2017-03-15
• Study Completion: 2017-03-15
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-28
• Last Update Posted: 2018-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to recurrence of clinical signs/symptoms of VVC	Up to Day 90 +/- 14 days	Time to recurrence of clinical signs/symptoms of VVC

Secondary Outcome Measures

Name	Time	Method
Rates of recurrence of culture confirmed VVC	Up to Day 90 +/- 14 days	Rates of recurrence of culture confirmed VVC
Rate of recurrence of clinical signs/symptoms of VVC	Up to Day 90 +/- 14 days	Rate of recurrence of clinical signs/symptoms of VVC
Time to recurrence of culture confirmed VVC	Up to Day 90 +/- 14 days	Time to recurrence of culture confirmed VVC
Rate of candida colonization	Up to Day 90 +/- 14 days	Rate of candida colonization

Trial Locations

Locations (23)

Precision Trials AZ; 🇺🇸 Phoenix, Arizona, United States

The Women's Clinical, P.A.; 🇺🇸 Little Rock, Arkansas, United States

Women's Health Care Research Corp; 🇺🇸 San Diego, California, United States

Olympian Clinical Research; 🇺🇸 Clearwater, Florida, United States

Women's Medical Research; 🇺🇸 Clearwater, Florida, United States

Altus Research Inc; 🇺🇸 Lake Worth, Florida, United States

New Age Medical Research Corporation; 🇺🇸 Miami, Florida, United States

Augusta University; 🇺🇸 Augusta, Georgia, United States

Clinical Trials Management LLC; 🇺🇸 Metairie, Louisiana, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

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