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

Sponsor
Cidara Therapeutics Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02888197
Collaborator
(none)
32
Enrollment
23
Locations
6.9
Actual Duration (Months)
1.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    32 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Actual Study Start Date :
    Aug 16, 2016
    Actual Primary Completion Date :
    Mar 15, 2017
    Actual Study Completion Date :
    Mar 15, 2017

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Rate of candida colonization [Up to Day 90 +/- 14 days]

      Rate of candida colonization

    2. Rate of recurrence of clinical signs/symptoms of VVC [Up to Day 90 +/- 14 days]

      Rate of recurrence of clinical signs/symptoms of VVC

    3. Time to recurrence of culture confirmed VVC [Up to Day 90 +/- 14 days]

      Time to recurrence of culture confirmed VVC

    4. Rates of recurrence of culture confirmed VVC [Up to Day 90 +/- 14 days]

      Rates of recurrence of culture confirmed VVC

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Precision Trials AZ Phoenix Arizona United States 85032
    2 The Women's Clinical, P.A. Little Rock Arkansas United States 72205
    3 Women's Health Care Research Corp San Diego California United States 92111
    4 Olympian Clinical Research Clearwater Florida United States 33756
    5 Women's Medical Research Clearwater Florida United States 33759
    6 Altus Research Inc Lake Worth Florida United States 33461
    7 New Age Medical Research Corporation Miami Florida United States 33186
    8 Augusta University Augusta Georgia United States 30912
    9 Clinical Trials Management LLC Metairie Louisiana United States 70006
    10 Wayne State University Detroit Michigan United States 48201
    11 Saginaw Valley Medical Research Group LLC Saginaw Michigan United States 48604
    12 Alliance Women's Research Group LLC Delran New Jersey United States 08075
    13 Lawrence OB GYN Clinical Research LLC Lawrenceville New Jersey United States 08648
    14 Soffolk OB/GYN Port Jefferson New York United States 11777
    15 Eastern Carolina Women's Center New Bern North Carolina United States 28562
    16 Hawthorne Medical Research Inc Winston-Salem North Carolina United States 27103
    17 Unified Women's Clinical Research - Hickory Winston-Salem North Carolina United States 27103
    18 Women's Health Research Columbus Ohio United States 43123
    19 Drexel University Philadelphia Pennsylvania United States 19102
    20 TMC Life Research Inc. Houston Texas United States 77054
    21 Clinical Trials of Texas Inc San Antonio Texas United States 78229
    22 Tidwewater Physicians for Women Norfolk Virginia United States 23502
    23 Seattle Women's Health, Research, Gynecology Seattle Washington United States 98105

    Sponsors and Collaborators

    • Cidara Therapeutics Inc.

    Investigators

    • Study Director: Alena Jandourek, MD, Cidara Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cidara Therapeutics Inc.
    ClinicalTrials.gov Identifier:
    NCT02888197
    Other Study ID Numbers:
    • CD101.TP.2.02
    First Posted:
    Sep 2, 2016
    Last Update Posted:
    Mar 2, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Mycoses
    Candidiasis
    Candidiasis, Vulvovaginal
    Vaginitis
    Recurrence

    Study Results

    No Results Posted as of Mar 2, 2018