Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Re… (NCT03167957) | Clinical Trial Compass
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 range18 Years – 65 Years
SexFEMALE
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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
What they're measuring
1
The proportion of subjects with clinical cure at the Test of Cure visit
Timeframe: 28 days
2
The proportion of subjects with mycological eradication at the Test of Cure visit