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Trial record 5 of 17 for:    "Vaginitis" | "Fluconazole"

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

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ClinicalTrials.gov Identifier: NCT02888197
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Cidara Therapeutics Inc.

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

Condition or disease
Candidiasis, Vulvovaginal Yeast Infection Mycoses 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.

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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 : August 16, 2016
Actual Primary Completion Date : March 15, 2017
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections




Primary Outcome Measures :
  1. Time to recurrence of clinical signs/symptoms of VVC [ Time Frame: Up to Day 90 +/- 14 days ]
    Time to recurrence of clinical signs/symptoms of VVC


Secondary Outcome Measures :
  1. Rate of candida colonization [ Time Frame: Up to Day 90 +/- 14 days ]
    Rate of candida colonization

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

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

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


Biospecimen Retention:   Samples Without DNA
Candida isolates


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888197


  Show 23 Study Locations
Sponsors and Collaborators
Cidara Therapeutics Inc.
Investigators
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Study Director: Alena Jandourek, MD Cidara Therapeutics

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Responsible Party: Cidara Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02888197     History of Changes
Other Study ID Numbers: CD101.TP.2.02
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Vaginitis
Recurrence
Mycoses
Candidiasis
Candidiasis, Vulvovaginal
Disease Attributes
Pathologic Processes
Vaginal Diseases
Genital Diseases, Female
Vulvovaginitis
Vulvitis
Vulvar Diseases