A Single-Center, Open-Label, Pilot Study to Evaluate the Efficacy and Safety of Oral Encochleated Amphotericin B (CAMB) in the Treatment of Fluconazole-Resistant Vulvovaginal Candidiasis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The proportion of subjects with clinical cure at the Test of Cure visit
研究概览
简要总结
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).
详细描述
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).
Approximately 16 women with fluconazole-resistant VVC will be randomized to either 200 mg or 400 mg oral CAMB for 14 days. The primary objectives of this study are to assess the clinical cure rate, mycology eradication and responder outcome. The secondary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female 18-65 years
- •Informed Consent
- •Clinical diagnosis of fluconazole-resistant VVC
- •Negative pregnancy test
- •Vaginal pH ≤ 4.5
排除标准
- •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
研究组 & 干预措施
CAMB 200 mg
200 mg CAMB Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
CAMB 400 mg
400 mg CAMB Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
结局指标
主要结局
The proportion of subjects with clinical cure at the Test of Cure visit
时间窗: 28 days
Resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment
The proportion of subjects with mycological eradication at the Test of Cure visit
时间窗: 28 days
Negative culture for growth of baseline Candida
次要结局
- Incidence of treatment emergent adverse events(28 days)