2023-510227-30-00招募中2 期
Phase II Randomized Clinical Trial of quinacrine versus metronidazole in resistant giardiasis in children: Quin4Kids
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz5 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年6月5日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.
研究概览
简要总结
To demonstrate the safety and non-inferior anti-giardia activity of oral quinacrine (QC) 6mg/kg/day administered every 8h for a period of 5 days compared to standard therapy (metronizadole high doses) in resistant intestinal giardiasis in children aged 1 to 18 years of age.
研究设计
- 分配方式
- Randomized
- 主要目的
- Phase II, open-label, randomized, multicentre clinical trial.
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Children aged 1 to 18 years of age.
- •Diagnosed with intestinal giardiasis.
- •Informed consent/assent.
- •Refractory to first line treatment
排除标准
- •History of allergy or previous positive skin-test reaction to any of the drug compounds included.
- •Liver disease and/or liver enzymes > x
- •Pregnant woman.
- •Oral intolerance.
结局指标
主要结局
Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.
Proportion of participants achieving microbiological eradication of Giardia intestinalis in each study arm.
次要结局
- Plasma drug concentration at the different time-points (Pharmacokinetic data).
- Hair drug concentration at the different time-points (Pharmacokinetic data).
- Proportion of patients with any adverse event.
- Proportion of drug discontinuation due to adverse effects. Tolerability.
- Proportion of strains carrying gene mutations related with metronidazole resistance.
- Proportion of co-parasitation.
- To generate pharmacokinetic data for the development of a specific pediatric galenic formulation.
- To obtain a cohort of resistant giardia isolates for further genetic characterization and/or cluster study.
- To characterize the cohort of pediatric patients harbouring resistant strains.
研究者
Talía Sainz Costa
Scientific
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
研究点 (5)
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