An MRI Ancillary Study of Malaria Fever Control RCT

疟疾发热控制的 MRI 辅助随机对照试验

基本信息

  • 批准号:
    10343754
  • 负责人:
  • 金额:
    $ 24.66万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-03-15 至 2025-01-31
  • 项目状态:
    未结题

项目摘要

Contact PD/PI: BIRBECK, GRETCHEN L. ABSTRACT Despite eradication efforts, ~400,000 African children sustained brain injuries as a result of CNS malaria in 2016. A higher maximum temperature (Tmax) during the acute malaria infection is an established risk factor for neurologic sequelae and a randomized controlled trial (RCT) of aggressive antipyretic therapy with acetaminophen and ibuprofen began enrollment in Malawi in 2019 (R01NS102176) with expansion into Zambia pending. In this clinical trial, the primary outcome is Tmax during the acute infection. However, the antipyretic therapies used in this RCT may offer neuroprotective benefits without affecting Tmax--for example, neuroprotection through anti-inflammatory mechanisms. In this ancillary study, we propose to use neuroimaging in the context of the RCT to further evaluate the potential neuroprotective effects of aggressive antipyretic therapy for CNS malaria and explore possible mechanisms for these effects. Comparing children allocated to aggressive antipyretic therapy vs. usual care on the prevalence of structural brain abnormalities after recovery from CNS malaria will facilitate the evaluation of non-fever pathways for neuroprotection. Both Zambia and Malawi have an unusually well developed infrastructure for advanced imaging in the academic Brain MRIs will be obtained in children enrolled in the RCT at 1- and 12-months post recovery. Analyses will be completed comparing the odds of having any structural injury based upon RCT treatment allocation and based upon (Tmax) stratified by treatment allocation to assess changes specifically related to response to therapy in terms of fever reduction. Potential mechanisms of aggressive antipyretic-related injury will be evaluated including assessments for treatment-related CNS bleeds. Neuroimaging is a well-established, valid proxy for neurological outcomes after brain injury including in pediatric CNS malaria. Adding this MRI ancillary study to our fever RCT may elucidate mechanisms of treatment-associated injury and allow for early identification of neuroprotection from aggressive antipyretic use that would otherwise require long-term follow-up for cognitive and behavioral assessments. This MRI ancillary study when added to the Fever RCT will provide critical insights that could inform future neuroprotective studies of malaria that might incorporate imaging to optimize study design. centers where the RCT using aggressive antipyretic therapy will be conducted. Page 7 Project Summary/Abstract
联系PD/PI: BIRBECK, GRETCHEN L。

项目成果

期刊论文数量(0)
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科研奖励数量(0)
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GRETCHEN L. BIRBECK其他文献

GRETCHEN L. BIRBECK的其他文献

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{{ truncateString('GRETCHEN L. BIRBECK', 18)}}的其他基金

Global Research Endeavors to Advance Treatment of Neurological Disorders in Africa (GREAT Neurology)
全球研究致力于推进非洲神经系统疾病的治疗(GREAT Neurology)
  • 批准号:
    10611348
  • 财政年份:
    2021
  • 资助金额:
    $ 24.66万
  • 项目类别:
Global Research Endeavors to Advance Treatment of Neurological Disorders in Africa (GREAT Neurology)
全球研究致力于推进非洲神经系统疾病的治疗(GREAT Neurology)
  • 批准号:
    10397647
  • 财政年份:
    2021
  • 资助金额:
    $ 24.66万
  • 项目类别:
Global Research Endeavors to Advance Treatment of Neurological Disorders in Africa (GREAT Neurology)
全球研究致力于推进非洲神经系统疾病的治疗(GREAT Neurology)
  • 批准号:
    10238395
  • 财政年份:
    2021
  • 资助金额:
    $ 24.66万
  • 项目类别:
An MRI Ancillary Study of Malaria Fever Control RCT
疟疾发热控制的 MRI 辅助随机对照试验
  • 批准号:
    10556361
  • 财政年份:
    2020
  • 资助金额:
    $ 24.66万
  • 项目类别:
Collaborative HIV Investigations of Antiretroviral Neuropsychiatric Toxicities in Zambia (CHANTZ): Protease Inhibitor Impact on Pediatric Cerebrovasculature and Mood
赞比亚抗逆转录病毒神经精神毒性合作艾滋病毒调查 (CHANTZ):蛋白酶抑制剂对儿童脑血管和情绪的影响
  • 批准号:
    10252756
  • 财政年份:
    2020
  • 资助金额:
    $ 24.66万
  • 项目类别:
An MRI Ancillary Study of Malaria Fever Control RCT
疟疾发热控制的 MRI 辅助随机对照试验
  • 批准号:
    10117293
  • 财政年份:
    2020
  • 资助金额:
    $ 24.66万
  • 项目类别:
Collaborative HIV Investigations of Antiretroviral Neuropsychiatric Toxicities in Zambia (CHANTZ): Protease Inhibitor Impact on Pediatric Cerebrovasculature and Mood
赞比亚抗逆转录病毒神经精神毒性合作艾滋病毒调查 (CHANTZ):蛋白酶抑制剂对儿童脑血管和情绪的影响
  • 批准号:
    9925503
  • 财政年份:
    2020
  • 资助金额:
    $ 24.66万
  • 项目类别:
An MRI Ancillary Study of Malaria Fever Control RCT
疟疾发热控制的 MRI 辅助随机对照试验
  • 批准号:
    9884625
  • 财政年份:
    2020
  • 资助金额:
    $ 24.66万
  • 项目类别:
Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance
中枢神经系统疟疾中的强力退热药:评估退热功效和寄生虫清除的随机对照试验
  • 批准号:
    9923006
  • 财政年份:
    2017
  • 资助金额:
    $ 24.66万
  • 项目类别:
Aggressive Antipyretics in CNS Malaria: A Randomized-Controlled Trial Assessing Antipyretic Efficacy and Parasite Clearance
中枢神经系统疟疾中的强力退热药:评估退热功效和寄生虫清除的随机对照试验
  • 批准号:
    10179500
  • 财政年份:
    2017
  • 资助金额:
    $ 24.66万
  • 项目类别:

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