Clinical trial NCT02888197: Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Candidiasis, Vulvovaginal
Yeast Infection
Mycoses
Moniliasis, Vulvovaginal
Vaginitis, Monilial
Lead sponsor: Cidara Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 32
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to recurrence of clinical signs/symptoms of VVC
timeFrame: Up to Day 90 +/- 14 days
Secondary outcomes:
measure: Rate of candida colonization
timeFrame: Up to Day 90 +/- 14 days
measure: Rate of recurrence of clinical signs/symptoms of VVC
timeFrame: Up to Day 90 +/- 14 days
measure: Time to recurrence of culture confirmed VVC
timeFrame: Up to Day 90 +/- 14 days
measure: Rates of recurrence of culture confirmed VVC
timeFrame: Up to Day 90 +/- 14 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials AZ
state: Arizona
city: Little Rock
country: United States
facility: The Women's Clinical, P.A.
state: Arkansas
city: San Diego
country: United States
facility: Women's Health Care Research Corp
state: California
city: Clearwater
country: United States
facility: Olympian Clinical Research
state: Florida
city: Clearwater
country: United States
facility: Women's Medical Research
state: Florida
city: Lake Worth
country: United States
facility: Altus Research Inc
state: Florida
city: Miami
country: United States
facility: New Age Medical Research Corporation
state: Florida
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Metairie
country: United States
facility: Clinical Trials Management LLC
state: Louisiana
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saginaw
country: United States
facility: Saginaw Valley Medical Research Group LLC
state: Michigan
city: Delran
country: United States
facility: Alliance Women's Research Group LLC
state: New Jersey
city: Lawrenceville
country: United States
facility: Lawrence OB GYN Clinical Research LLC
state: New Jersey
city: Port Jefferson
country: United States
facility: Soffolk OB/GYN
state: New York
city: New Bern
country: United States
facility: Eastern Carolina Women's Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research Inc
state: North Carolina
city: Winston-Salem
country: United States
facility: Unified Women's Clinical Research - Hickory
state: North Carolina
city: Columbus
country: United States
facility: Women's Health Research
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Houston
country: United States
facility: TMC Life Research Inc.
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc
state: Texas
city: Norfolk
country: United States
facility: Tidwewater Physicians for Women
state: Virginia
city: Seattle
country: United States
facility: Seattle Women's Health, Research, Gynecology
state: Washington
Study officials:
affiliation: Cidara Therapeutics
name: Alena Jandourek, MD
role: STUDY_DIRECTOR
References: