WithdrawnPhase 2

Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis

Stopped: No longer target indication

United States0Started 2019-12

Plain-language summary

This is a single-center, open-label, pilot study to evaluate the efficacy of 14 days of CAMB dosing in subjects with fluconazole-resistant vulvovaginal candidiasis (VVC).

Who can participate

Age range

18 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female 18-65 years * Informed Consent * Clinical diagnosis of fluconazole-resistant VVC * Negative pregnancy test * Vaginal pH ≤ 4.5 Exclusion Criteria: * Intolerance or hypersensitivity to any amphotericin B (AMB) product or to azole antifungal drugs * Receiving antifungal therapy unrelated to VVC or has evidence of systemic fungal infections requiring antifungal therapy * Received antifungal treatment for VVC within past 10 days except fluconazole, subjects must discontinue fluconazole after informed consent * Has another cause or suspected cause of vulvovaginitis * Has active HPV * Has other urogenital infection * Has other vaginal or vulvar condition that would confound interpretation of clinical response * Has significant laboratory abnormality at screening * Has Type I diabetes, use of insulin, HbA1c\>10 * Exposure to any investigational product within 30 days of screening * Has other condition that would interfere with subject ability to provide informed consent or put subject at undue risk

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of subjects with clinical cure at the Test of Cure visit

Timeframe: 28 days

The proportion of subjects with mycological eradication at the Test of Cure visit

Timeframe: 28 days

Trial details

NCT IDNCT03167957

SponsorMatinas BioPharma Nanotechnologies, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-12

View on ClinicalTrials.gov More Vulvovaginal Candidiases trials