Assessment of a Novel Fixed-dose Combination (FDC) Drug VR-AD-1005 for the Treatment of Acute Watery Diarrhea in Cholera: a Phase II, Randomized, Placebo-controlled, Double-blinded Efficacy and Safety Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Stool Output Volume During Treatment Period.
研究概览
简要总结
Cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. Cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. However, antimicrobial treatment is given to patients with moderate to severe diarrhea. The consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. No antisecretory drug has so far been proven successful. In a phase II clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug VR-AD-1005 for treating cholera. Changes in stool volume and rehydration therapy will be assessed for VR-AD-1005 in comparison with placebo. If successful, this will be a huge advance in managing cholera and other secretory diarrhea. The introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens
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)
盲法说明
randomized, placebo-controlled, double-blinded
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent.
- •Adults, both genders aged 18-65 years.
- •Acute watery diarrhea (defined as passage of three or more liquid stools within the 24 hours before admission) with severe dehydration on arrival.
- •Detection of V. cholerae by rapid diagnostic assay (e.g. dark field microscopy).
排除标准
- •Known or suspected hypersensitivity to trial product(s) or related products.
- •Subjects with passage of bloody stools or muco-purulent stools.
- •Subjects with chronic diarrhea (>4 weeks of Diarrhea).
- •Clinically significant concomitant systemic disease (i.e. cardiovascular diseases including heart failure, acute kidney injury, sepsis or life-threatening malignant cancer).
- •Mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation.
- •History of receiving antimicrobial or antidiarrheal drugs within 6 hours prior to admission.
- •Positive urine pregnancy test for all female patients
- •Failure to obtain informed consent.
- •Failure to definitively diagnose cholera via culture or RT-PCR
研究组 & 干预措施
VR-AD-1005
干预措施: VR-AD-1005 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Stool Output Volume During Treatment Period.
时间窗: Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours, e.g. hour 1, hour 6, hour 8, hour 10, hour 11, hour 22, hour 23, hour 26, etc.).
Means of stool output data expressed as ml/kg·h-1 for Treatment and Comparator groups.
次要结局
- Duration of Stool Output in Excess of 200 ml/Hour(Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).)
- Number of Unscheduled IV Rehydration Episodes Per Treatment(Unscheduled IV rehydration episodes were measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).)
- Volume of IV Rehydration, ml/kg(Volume of administered IV rehydration solution was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).)
- Time Until Last Liquid Stool(Liquid and solid stool output was measured by trained trial personnel and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).)
- Duration of Stool Output in Excess of 400 mL/Hour(Stool output volume was measured and recorded hourly for each participant for the entire duration of treatment (from enrollment up to 72 hours).)
- Participants With at Least One Adverse Event(From enrollment until the end of follow-up, up to 28 days)