PACTR202106780884401招募中2 期
ASSESSMENT OF A NOVEL FIXED DOSE COMBINATION (FDC) DRUG VR-AD-1005 FOR THE TREATMENT OF ACUTE WATERY DIARRHEA IN CHOLERA: A PHASE II, MULTICENTER, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE-BLINDED EFFICACY AND SAFETY TRIA
Vanessa Research Holdings Inc.0 个研究点目标入组 300 人开始时间: 2021年6月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •Signed informed consent.
- •Adults, both genders aged 18-55 years
- •Acute is mild to severe watery diarrhea (defined as the passage of three or more liquid stools within the 24 hours before admission, WHO severity assessment criteria. Diarrhea is defined as severe if the patient is passing over 8 liters of stool per day, as moderate if stool output is between 3 and 8 liters per day and as mild if the patient is passing less than 3 liters of stool per day).
- •Confirmation of cholera detection of cholera by rapid detection test (RDT), followed by confirmation via culture or RT-PCR (as available).
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products
- •Subjects with the passage of bloody stools or purulent stools
- •Subjects with chronic diarrhea
- •Clinically significant concomitant systemic disease (i.e. heart failure, acute kidney injury, sepsis or life-threatening malignant cancer)
- •Subjects suffering from CV abnormalities.
- •Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation.
- •History of receiving antimicrobial or antidiarrheal drugs prior to admission.
- •Positive urine pregnancy test for all female patients
- •Failure to obtain informed consent.
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