Improving Neonatal health Through Rapid malaria testing in Early Pregnancy with high-sensitivity Diagnostics (INTREPiD)
通过妊娠早期快速疟疾检测和高灵敏度诊断来改善新生儿健康 (INTREPiD)
基本信息
- 批准号:10405395
- 负责人:
- 金额:$ 140.77万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2022
- 资助国家:美国
- 起止时间:2022-04-01 至 2027-03-31
- 项目状态:未结题
- 来源:
- 关键词:AddressAfrica South of the SaharaAftercareAntimalarialsAreaClinicClinicalClinical TrialsCollaborationsCommunicable DiseasesComplementCountryDataDemocratic Republic of the CongoDetectionDevelopmentDiagnostic SensitivityDiagnostic testsDiscipline of obstetricsDoseDrug KineticsEnrollmentEpidemiologyFetal GrowthFirst Pregnancy TrimesterGoalsGuidelinesInfantInfectionInstitutionInterceptInterventionKenyaLeftLow Birth Weight InfantLow PrevalenceMalariaMalawiMeasuresModelingNeonatal MortalityNeonatologyOutcomeParasitesPlacentationPlasmodium falciparumPopulationPregnancyPregnancy OutcomePregnant WomenPremature BirthPrevention strategyPreventive therapyProphylactic treatmentPyrimethamine-SulfadoxineRandomizedRapid diagnosticsReportingResource-limited settingRiskSafetyScheduleSecond Pregnancy TrimesterSmall for Gestational Age InfantTestingThird Pregnancy TrimesterTreatment EfficacyTreatment ProtocolsUpdateWomanadverse pregnancy outcomeantenatalartemetherbenflumetolcohortdensitydesignearly pregnancyeffective therapyefficacy testingexperiencefetal losshigh risk populationimprovedinfant deathinfection riskinnovationmalaria infectionmathematical modelneonatal deathneonatal healthnovel strategiespharmacokinetics and pharmacodynamicsprenatalpreventprimary outcomescreeningsuccesstransmission processtreatment as usualtreatment strategy
项目摘要
Project Summary/Abstract
Newborn health has improved globally but there remains a critical need in resource-limited settings to reduce
neonatal mortality. Nearly all infant deaths in sub-Saharan Africa occur in babies that are small or low
birthweight, which often result from antenatal infections with Plasmodium falciparum. These malaria effects can
be partially mitigated by pregnancy-specific measures including the administration of monthly antenatal doses
of sulfadoxine-pyrimethamine as intermittent preventive therapy during pregnancy (IPTp-SP), but these are not
typically implemented until the 2nd trimester, and so do not mitigate the risks of infection in the 1st trimester. It
is now feasible to include 1st trimester screening for malaria parasites owing to: i) updated WHO guidelines that
recommend an expended schedule of 8 ANC contacts, with the first prior to 12 weeks gestation, ii) the
availability of high-sensitivity malaria rapid diagnostic tests (HS-RDT) with enhanced detection of low-density
infections, and iii) accumulated safety data that enable the use of Artemether-Lumefantrine (AL) for malaria
treatment in the 1st trimester. We hypothesize that, compared to women who enter ANC and receive usual
care, women who are screened in the 1st trimester with an HS-RDT will have a lower prevalence of a poor
pregnancy outcome, and we will test this through the Improving Neonatal health Through Rapid malaria testing
in Early Pregnancy with high-sensitivity Diagnostics (INTREPiD) study in Western Kenya and the Democratic
Republic of the Congo (DRC). In Aim 1, the INTREPiD study will enroll women in the 1st trimester and
randomize them 1:1 to usual care or to screening with an HS-RDT followed by treatment of positives with AL,
and then follow them through delivery. Following the 1st trimester intervention, all women will receive usual
ANC, including IPTp-SP. The primary outcome will be the composite outcome of low birthweight, small-for-
gestational age, preterm birth, fetal loss, or neonatal death. In Aim 2, we will measure the therapeutic efficacy
and pharmacokinetics of AL administration in the 1st trimester through a population PK study following standard
AL dosing and compare PK parameters with historical controls. In Aim 3, we will use trial data to model the
potential incremental benefits of enhanced-sensitivity diagnostics and alternate treatment regimens on the risk
of an adverse pregnancy outcome in order to maximize the impact of our trial data. Collectively these data will
guide the development and implementation of fresh approaches to intercept parasites early in pregnancy and
thereby enhance pregnancy outcomes and newborn health.
项目总结/文摘
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Steve Myer Taylor其他文献
Steve Myer Taylor的其他文献
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{{ truncateString('Steve Myer Taylor', 18)}}的其他基金
Improving Neonatal health Through Rapid malaria testing in Early Pregnancy with high-sensitivity Diagnostics (INTREPiD)
通过妊娠早期快速疟疾检测和高灵敏度诊断来改善新生儿健康 (INTREPiD)
- 批准号:
10597224 - 财政年份:2022
- 资助金额:
$ 140.77万 - 项目类别:
Estimating the incremental benefits on active malaria case detection of high-sensitivity rapid diagnostic tests
估计高灵敏度快速诊断测试对活动性疟疾病例检测的增量效益
- 批准号:
9805378 - 财政年份:2019
- 资助金额:
$ 140.77万 - 项目类别:
Estimating the incremental benefits on active malaria case detection of high-sensitivity rapid diagnostic tests
估计高灵敏度快速诊断测试对活动性疟疾病例检测的增量效益
- 批准号:
9974475 - 财政年份:2019
- 资助金额:
$ 140.77万 - 项目类别:
Impact of Sickle-Trait on Transcriptional Regulation in P. Falciparum Parasites
镰状性状对恶性疟原虫转录调控的影响
- 批准号:
9315425 - 财政年份:2017
- 资助金额:
$ 140.77万 - 项目类别:
Malaria chemoprevention in children with sickle cell anemia in Western Kenya
肯尼亚西部镰状细胞性贫血儿童的疟疾化学预防
- 批准号:
9279261 - 财政年份:2016
- 资助金额:
$ 140.77万 - 项目类别:
Malaria chemoprevention in children with sickle cell anemia in Western Kenya
肯尼亚西部镰状细胞性贫血儿童的疟疾化学预防
- 批准号:
9882892 - 财政年份:2016
- 资助金额:
$ 140.77万 - 项目类别:
Molecular pathogenesis and genetic diversification of childhood falciparum malari
儿童恶性疟的分子发病机制和遗传多样性
- 批准号:
8660031 - 财政年份:2012
- 资助金额:
$ 140.77万 - 项目类别:
Molecular pathogenesis and genetic diversification of childhood falciparum malari
儿童恶性疟的分子发病机制和遗传多样性
- 批准号:
8474694 - 财政年份:2012
- 资助金额:
$ 140.77万 - 项目类别:
Molecular pathogenesis and genetic diversification of childhood falciparum malari
儿童恶性疟的分子发病机制和遗传多样性
- 批准号:
8542114 - 财政年份:2012
- 资助金额:
$ 140.77万 - 项目类别:
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