A Multi-Center Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of Oral Encochleated Amphotericin B (CAMB/MAT2203) Compared With Oral Fluconazole in the Treatment of Moderate to Severe Vulvovaginal Candidiasis (VVC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 23
- 主要终点
- Clinical Outcome Assessed at Test of Cure Visit
研究概览
简要总结
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
详细描述
This is a multi-center, randomized study to evaluate the safety, tolerability, and efficacy of 200 mg CAMB and 400 mg CAMB compared with a single 150 mg dose of fluconazole in the treatment of moderate to severe VVC.
Approximately 75 women with moderate to severe VVC will be randomized to 1 of 3 treatment groups (200 mg CAMB, 400 mg CAMB, or fluconazole) to achieve approximately 25 subjects in each group. The primary objective of this study is to evaluate the safety of 200 mg and 400 mg doses of oral CAMB for 5 days compared with a single 150 mg dose of oral fluconazole in subjects with moderate to severe VVC. The secondary efficacy objectives of this study included the clinical cure rate, mycology eradication and responder outcome. Tertiary objectives include pharmacokinetics.
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
- Single (Outcomes Assessor)
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
- •Informed consent
- •Clinical diagnosis of moderate to severe VVC
- •Negative pregnancy test
- •Vaginal pH less than 4.5
排除标准
- •Has an 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
- •Has received treatment for VVC within the past 30 days or has experienced 4 or more episodes of VVC in the past 12 months
- •Has another cause of vulvovaginitis
- •Has other urogenital infection(s) that would potentially alter their response to disease
- •Has another vaginal or vulvar condition that would confound the interpretation of clinical response
- •Has significant laboratory abnormality at screening
- •Has any known azole-resistant Candida infection;
- •Has any other condition the Investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or puts the subject at undue risk
研究组 & 干预措施
CAMB 200 mg
200 mg CAMB (MAT2203) Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
CAMB 400 mg
400 mg CAMB (MAT2203) Oral Amphotericin B
干预措施: Oral Encochleated Amphotericin B (CAMB) (Drug)
Fluconazole 150 mg
Fluconazole Diflucan
干预措施: Fluconazole (Drug)
结局指标
主要结局
Clinical Outcome Assessed at Test of Cure Visit
时间窗: 12 days
Number of patients determined to be a Clinical Cure (resolution of the VVC signs and symptoms that were present at baseline without further antifungal treatment); Clinical Failure (incomplete resolution of signs and symptoms of VVC that were present at baseline or new signs and symptoms have developed and require the initiation of non-study antifungal drugs); or Clinical indeterminate (insufficient data are available to determine if the subject is a cure or failure)
次要结局
- Mycological Outcome Assessed at Test of Cure(12 days)
- Overall Response(12 Days)
- Change in Composite Clinical Cure Score(Between randomization visit (Baseline) and Day 12 visit (Test of Cure))