疟疾康复的轨迹和机制：一项观察性研究 (SCRIPT)
在患者转录组 (SCRIPT)（疟疾）研究中搜索恢复的相关性
This observational research study aims to answer the question: 'Which aspects of human biology play an important role in recovery from symptomatic malaria?'
In particular, the researchers aim to identify human genes for which the level of gene activity reflects the patient's overall rate of recovery. The researchers believe this approach may reveal new targets for adjunctive therapies.
The researchers aim to recruit 240 people, of all ages, who have been diagnosed with symptomatic malaria at selected hospitals in London. Blood samples, urine samples, and clinical information will be collected over the 14 days following malaria diagnosis.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习地点
-
-
-
London、英国
- Imperial College Healthcare NHS Trust
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film
描述
Inclusion Criteria:
Patients of any age with symptomatic malaria confirmed by asexual stage parasitaemia (of any Plasmodium species) on blood film.
Exclusion Criteria:
Patients with asymptomatic malaria; Patients with congenital malaria; Patients with Plasmodium gametocytaemia only; Patients with known HIV; Patients who have received antimalarial treatment for symptomatic malaria in the 28 days prior to hospital presentation; Patients who explicitly deny consent.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Genes for which expression (level of gene activity) correlates with a 'composite recovery score'
大体时间：Each study participant will be assessed over the 14 days following malaria diagnosis
|
The 'composite recovery score' will be calculated by principal component analysis of rates of recovery for individual markers of tissue, organ, or organ system dysfunction, and extraction of the value of the first principal component for each participant. Genes for which expression correlates with the 'composite recovery score' will be identified by whole blood transcriptome analysis. |
Each study participant will be assessed over the 14 days following malaria diagnosis
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Genes for which expression (level of gene activity) correlates with rate of recovery for individual markers of tissue, organ, or organ system dysfunction
大体时间：Each study participant will be assessed over the 14 days following malaria diagnosis
|
Genes for which expression correlates with the individual markers of tissue, organ, or organ system dysfunction will be identified by whole blood transcriptome analysis. |
Each study participant will be assessed over the 14 days following malaria diagnosis
|
|
Rate of recovery for individual markers of tissue, organ, or organ system dysfunction
大体时间：Each study participant will be assessed over the 14 days following malaria diagnosis
|
Rates of recovery will be calculated for individual markers of tissue, organ, or organ system dysfunction |
Each study participant will be assessed over the 14 days following malaria diagnosis
|
|
Sequences of clinical events predictive of recovery, as determined by Bayesian inference of dynamic pathways using the HyperTraPS statistical platform
大体时间：Each study participant will be assessed over the 14 days following malaria diagnosis
|
Hypercubic transition path sampling (HyperTraPS) will be used to characterise patterns of recovery and identify predictors of fast vs slow recovery |
Each study participant will be assessed over the 14 days following malaria diagnosis
|
合作者和调查者
调查人员
- 首席研究员：Aubrey Cunnington, PhD、Imperial College London
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.