NCT00147368已完成1 期
Pharmacokinetic-Pharmacodynamic Study of Adjunctive Arginine in Falciparum Malaria
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- exhaled and systemic nitric oxide production
研究概览
简要总结
Acute falciparum malaria is associated with low plasma arginine and impaired nitric oxide (NO) production. Both are associated with poor outcome. This study will examine the safety and effect of escalating doses of arginine in falciparum malaria. It will determine whether arginine can increase NO production and have an effect on NO-dependent physiological measurements. The hypothesis is that arginine: will be safe in falciparum malaria; will return plasma arginine concentration to normal/supranormal levels; will increase systemic and exhaled NO; reduces oxidant stress; and improves a number of NO-dependent physiological measures of relevance to malaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-60 years
- •P. falciparum parasitemia (1,000-100,000 parasites/ul).
- •Clinical syndrome consistent with malaria associated with documented fever (axillary temperature > 38℃) or self-reported history of fever in the last 48 hours with no other cause present
- •Commenced oral quinine ≤ 18 hours prior to scheduled commencement of arginine
- •An indication for hospital admission (eg relative cannot look after/supervise treatment at home but not having any warning signs or severe malaria criteria in "exclusion criteria" below)
- •Informed consent obtained
排除标准
- •Pregnancy or lactation
- •Mixed infection with P. falciparum and P. vivax
- •Warning signs of altered mental state and inability to sit unaided
- •Features of severe/complicated malaria
- •Systolic blood pressure (BP) < 100 mmHg
- •Serious underlying disease (cardiac, hepatic, kidney)
- •Initial iSTAT test showing any of the following values:
- •glucose < 4 mmol/L;
- •K+ ≥ 4.2 meq/L;
- •Cl- > 106 meq/L;
- •HCO3- < 20 meq/L.
- •Known allergy to L-arginine
- •Concurrent therapy with any of the following medications:
- •spironolactone;
- •oral nitrates;
- •phosphodiesterase inhibitor (eg sildenafil [Viagra]);
- •alpha-blocking antihypertensive agents (eg prazosin);
- •L-arginine.
结局指标
主要结局
exhaled and systemic nitric oxide production
endothelial function
次要结局
- pharmacodynamic (PD) parameters
- a priori subgroup analysis: endothelial function in those with baseline impairment of function
- safety
- pharmacokinetic (PK) parameters
- oxidant stress
- gas transfer
- endothelial activation
研究者
研究点 (1)
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