Candidiasis, VulvovaginalNCT02888197
Non-Interventional Extension to Investigate Recurrence of Vulvovaginal Candidiasis and Candida Colonization
An observational study of Candidiasis, Vulvovaginal and Yeast Infection, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 23 sites in United States.
Trial summary
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Candidiasis, Vulvovaginal, Yeast Infection, Mycoses
- How many people
- 32 participants
- Where
- 23 sitesUnited States
- Study dates
- 16 Aug 2016to 15 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Augusta University
Augusta, Georgia, 30912
Olympian Clinical Research
Clearwater, Florida, 33756
Women's Medical Research
Clearwater, Florida, 33759
Women's Health Research
Columbus, Ohio, 43123
Wayne State University
Detroit, Michigan, 48201
TMC Life Research Inc.
Houston, Texas, 77054
Altus Research Inc
Lake Worth, Florida, 33461
Lawrence OB GYN Clinical Research LLC
Lawrenceville, New Jersey, 08648
The Women's Clinical, P.A.
Little Rock, Arkansas, 72205
Clinical Trials Management LLC
Metairie, Louisiana, 70006
New Age Medical Research Corporation
Miami, Florida, 33186
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Tidwewater Physicians for Women
Norfolk, Virginia, 23502
Drexel University
Philadelphia, Pennsylvania, 19102
Precision Trials AZ
Phoenix, Arizona, 85032
Soffolk OB/GYN
Port Jefferson, New York, 11777
Alliance Women's Research Group LLC
Riverside Park, New Jersey, 08075
Saginaw Valley Medical Research Group LLC
Saginaw, Michigan, 48604
Clinical Trials of Texas Inc
San Antonio, Texas, 78229
Women's Health Care Research Corp
San Diego, California, 92111
Seattle Women's Health, Research, Gynecology
Seattle, Washington, 98105
Hawthorne Medical Research Inc
Winston-Salem, North Carolina, 27103
Unified Women's Clinical Research - Hickory
Winston-Salem, North Carolina, 27103
About this study
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
Non-interventional extension study to investigate VVC recurrence and candida colonization following the P2 acute VVC study
Read the 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.
- Conditions
- Candidiasis, Vulvovaginal, Yeast Infection, Mycoses, Moniliasis, Vulvovaginal, Vaginitis, Monilial
- Medical subject headings
- Candidiasis, Vulvovaginal, Mycoses
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence of clinical signs/symptoms of VVC
Time to recurrence of clinical signs/symptoms of VVC
Measured: Up to Day 90 +/- 14 days
Secondary outcomes (4)
Rate of candida colonization
Rate of candida colonization
Measured: Up to Day 90 +/- 14 days
Rate of recurrence of clinical signs/symptoms of VVC
Rate of recurrence of clinical signs/symptoms of VVC
Measured: Up to Day 90 +/- 14 days
Time to recurrence of culture confirmed VVC
Time to recurrence of culture confirmed VVC
Measured: Up to Day 90 +/- 14 days
Rates of recurrence of culture confirmed VVC
Rates of recurrence of culture confirmed VVC
Measured: Up to Day 90 +/- 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study start16 Aug 2016
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candidiasis, VulvovaginalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alena Jandourek, MD, Study director, Cidara Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888197
- Sponsor's protocol ID
- CD101.TP.2.02
- Status last verified
- Feb 2018
- First submitted
- 30 Aug 2016
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02888197
- Acronym / sponsor ID
- CD101.TP.2.02
- Conditions
- Candidiasis, Vulvovaginal, Yeast Infection, Mycoses, Moniliasis, Vulvovaginal, Vaginitis, Monilial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Industry (pharma, biotech, devices)
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 2 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Rate of candida colonization
Time frame: Up to Day 90 +/- 14 days
Rate of recurrence of clinical signs/symptoms of VVC
Time frame: Up to Day 90 +/- 14 days
Time to recurrence of culture confirmed VVC
Time frame: Up to Day 90 +/- 14 days
Rates of recurrence of culture confirmed VVC
Time frame: Up to Day 90 +/- 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alena Jandourek, MD study director
Cidara Therapeutics
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidiasis, Vulvovaginal and Yeast Infection, run by Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence of clinical signs/symptoms of VVC (time frame: Up to Day 90 +/- 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.