通过高灵敏度诊断的早孕期疟疾快速检测改善新生儿健康 (INTREPiD)
2024年1月23日 更新者：Duke University
通过高灵敏度的早孕期疟疾快速检测改善新生儿健康
INTREPiD 研究的目的是将第 1 个月的疟疾寄生虫筛查与高灵敏度疟疾快速诊断测试进行比较，然后使用蒿甲醚-苯泛群 (AL) 治疗测试阳性的妇女与常规产前护理对复合不良妊娠结局的影响，包括低出生体重、小于胎龄儿、早产、流产或新生儿死亡。
研究概览
地位
招聘中
详细说明
INTREPiD 是一项双臂、开放标签、平行分配的随机试验，该试验采用高灵敏度快速诊断测试 (HS-RDT) 对恶性疟原虫寄生虫进行妊娠早期筛查的策略。 参与者将是在肯尼亚和刚果民主共和国恶性疟原虫疟疾流行地区的第一个三个月到产前诊所就诊的所有妊娠妇女。
在同意并登记后，妇女将按 1:1 的比例分配到常规产前护理或干预。 干预将是在第一个三个月使用 HS-RDT 在母体外周血中进行恶性疟原虫感染的单次筛查。 在 HS-RDT 检测中恶性疟原虫检测呈阳性的女性将接受单疗程蒿甲醚-苯泛群 (AL) 治疗，然后恢复常规产前护理。
将跟踪参与者的分娩过程，然后是他们后代出生后的第一个月。
假设是，与常规产前检查相比，在妊娠早期筛查女性恶性疟原虫并在 AL 呈阳性时进行治疗将降低不良妊娠结局的风险。
研究类型
介入性
注册 (估计的)
2500
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Stephen James, MPH
- 电话号码：919-668-0420
- 邮箱：stephen.james@duke.edu
研究联系人备份
- 姓名：Irene Okumu
- 电话号码：919-660-6321
- 邮箱：irene.okumu@duke.edu
学习地点
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Kinshasa、刚果民主共和国
- 招聘中
- Kinshasa School of Public Health
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接触：
- Antoinette Tshefu, MD, PhD, MPH
- 电话号码：+243998551185
- 邮箱：antotshe@yahoo.com
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接触：
- Jean Okitawutshu, MD
- 邮箱：jeanokitawutshu@gmail.com
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首席研究员：
- Antoinette Tshefu, MD, PhD, MPH
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Eldoret、肯尼亚
- 招聘中
- Moi University
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接触：
- Jeremiah Laktabai, MBChB, MMED
- 电话号码：+254532033235
- 邮箱：jklaktabai@gmail.com
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接触：
- Joseph Kipkoech
- 电话号码：+254720393547
- 邮箱：josepheddykipkoech@gmail.com
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首席研究员：
- Jeremiah Laktabai, MBChB, MMED
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 40年 (孩子、成人)
接受健康志愿者
不
描述
纳入标准：
- 年龄在16周岁至40周岁（含）之间
- 超声估计胎龄小于 13 6/7 周（含）的可行单胎妊娠
- 未感染HIV
- 愿意参加学习计划
- 计划在怀孕期间和分娩后 1 个月内留在研究区域
- 愿意在研究附属的医疗机构中分娩
排除标准：
- 需要根据当地指南转诊接受专门护理的高危妊娠
- 需要更高级别护理的筛选时的活跃医疗问题
- 筛选前 2 周内接受抗疟药
- 既往对蒿甲醚或苯泛群过敏或其他禁止接受这两种药物的情况
- 目前参与另一项临床研究
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：放映
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：HS-RDT 筛查/AL 治疗
孕妇将接受疟疾 HS-RDT 筛查，如果呈阳性，则接受蒿甲醚-苯蒽治疗
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检测恶性疟原虫HRP-II抗原1 方法：侧流；出结果时间：20 分钟；样本类型：指尖全血；样品量：5µl；储存条件：1-30°C；保质期：12个月；灵敏度/特异性：99.0%/98.6%
其他名称：
口服片剂：3 天内 6 剂 80/480 毫克
其他名称：
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无干预：常规产前检查
孕妇将接受常规的产前检查
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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 |
|---|---|---|
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不良妊娠结局的复合数
大体时间：登记至产后 28 天（包括每次产前检查）
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不良妊娠结局定义为低出生体重（<2500 克）或早产（< 37 0/7 周）或小于胎龄儿 (GA)（< GA 的第 10 个百分位体重）或流产，定义为 a.自然流产（流产 < 22 0/7 周妊娠）或 b.死产（流产 ≥ 22 0/7 周妊娠）或新生儿死亡（活产并在出生后第 28 天前死亡）。
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登记至产后 28 天（包括每次产前检查）
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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出生体重
大体时间：送货
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出生体重克
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送货
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低出生体重婴儿数
大体时间：送货
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< 2500 克，活产
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送货
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胎龄 (GA)
大体时间：送货
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周/天分娩时的 GA，活产
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送货
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早产儿
大体时间：送货
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< 37 0/7 周，活产
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送货
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小于胎龄儿数
大体时间：送货
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胎龄体重 < 第 10 个百分位数，活产
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送货
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不良新生儿结局的数量
大体时间：送货
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低出生体重或早产或小于胎龄儿
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送货
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自然流产数
大体时间：送货
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流产 < 妊娠 22 0/7 周
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送货
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死胎数
大体时间：送货
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流产≥ 22 0/7 周妊娠
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送货
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早期胎儿死亡数
大体时间：送货
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妊娠丢失 22 0/7 - 27 6/7 周妊娠
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送货
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晚期胎儿死亡数
大体时间：送货
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流产≥ 28 0/7 周妊娠
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送货
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流产次数
大体时间：送货
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自然流产或死产
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送货
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新生儿死亡数
大体时间：交货后 28 天交货
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出生后第 28 天之前，活产
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交货后 28 天交货
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围产期死亡人数
大体时间：交货后 28 天交货
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晚期胎儿死亡或新生儿死亡
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交货后 28 天交货
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怀孕期间临床疟疾的发病率
大体时间：分娩登记（包括每次产前检查）
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通过光学显微镜或快速诊断测试检测到外周疟原虫血症的母体症状
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分娩登记（包括每次产前检查）
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分娩时患有外周寄生虫血症的母亲人数
大体时间：送货
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通过 PCR 分娩时母体外周寄生虫血症
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送货
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平均母体血红蛋白浓度
大体时间：注册和交付
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母体血红蛋白 (g/dL)
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注册和交付
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分娩时患有贫血的母亲人数
大体时间：送货
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母体 Hb 浓度 ≤ 11 g/dL
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送货
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分娩时患有严重贫血的母亲人数
大体时间：送货
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母体 Hb 浓度 ≤ 7 g/dL
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送货
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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孕产妇严重不良事件的数量
大体时间：入学至产后 28 天
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母亲的严重不良事件
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入学至产后 28 天
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先天性畸形婴儿人数
大体时间：交货后 28 天交货
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出生后 28 天内确定的先天性畸形
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交货后 28 天交货
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需要住院或进行急性医学评估的后代数量
大体时间：交货后 28 天交货
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出生后 28 天内住院或进行急性医学评估
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交货后 28 天交货
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Steve M Taylor, MD, MPH、Duke University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
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- Lawn JE, Blencowe H, Oza S, You D, Lee AC, Waiswa P, Lalli M, Bhutta Z, Barros AJ, Christian P, Mathers C, Cousens SN; Lancet Every Newborn Study Group. Every Newborn: progress, priorities, and potential beyond survival. Lancet. 2014 Jul 12;384(9938):189-205. doi: 10.1016/S0140-6736(14)60496-7. Epub 2014 May 19. Erratum In: Lancet. 2014 Jul 12;384(9938):132.
- Cottrell G, Moussiliou A, Luty AJ, Cot M, Fievet N, Massougbodji A, Deloron P, Tuikue Ndam N. Submicroscopic Plasmodium falciparum Infections Are Associated With Maternal Anemia, Premature Births, and Low Birth Weight. Clin Infect Dis. 2015 May 15;60(10):1481-8. doi: 10.1093/cid/civ122. Epub 2015 Feb 18.
- Das S, Jang IK, Barney B, Peck R, Rek JC, Arinaitwe E, Adrama H, Murphy M, Imwong M, Ling CL, Proux S, Haohankhunnatham W, Rist M, Seilie AM, Hanron A, Daza G, Chang M, Nakamura T, Kalnoky M, Labarre P, Murphy SC, McCarthy JS, Nosten F, Greenhouse B, Allauzen S, Domingo GJ. Performance of a High-Sensitivity Rapid Diagnostic Test for Plasmodium falciparum Malaria in Asymptomatic Individuals from Uganda and Myanmar and Naive Human Challenge Infections. Am J Trop Med Hyg. 2017 Nov;97(5):1540-1550. doi: 10.4269/ajtmh.17-0245. Epub 2017 Aug 18.
- Vasquez AM, Medina AC, Tobon-Castano A, Posada M, Velez GJ, Campillo A, Gonzalez IJ, Ding X. Performance of a highly sensitive rapid diagnostic test (HS-RDT) for detecting malaria in peripheral and placental blood samples from pregnant women in Colombia. PLoS One. 2018 Aug 2;13(8):e0201769. doi: 10.1371/journal.pone.0201769. eCollection 2018.
- ACOG committee opinion no. 561: Nonmedically indicated early-term deliveries. Obstet Gynecol. 2013 Apr;121(4):911-915. doi: 10.1097/01.AOG.0000428649.57622.a7.
- Kakuru A, Jagannathan P, Muhindo MK, Natureeba P, Awori P, Nakalembe M, Opira B, Olwoch P, Ategeka J, Nayebare P, Clark TD, Feeney ME, Charlebois ED, Rizzuto G, Muehlenbachs A, Havlir DV, Kamya MR, Dorsey G. Dihydroartemisinin-Piperaquine for the Prevention of Malaria in Pregnancy. N Engl J Med. 2016 Mar 10;374(10):928-39. doi: 10.1056/NEJMoa1509150.
- Lawn JE, Blencowe H, Waiswa P, Amouzou A, Mathers C, Hogan D, Flenady V, Froen JF, Qureshi ZU, Calderwood C, Shiekh S, Jassir FB, You D, McClure EM, Mathai M, Cousens S; Lancet Ending Preventable Stillbirths Series study group; Lancet Stillbirth Epidemiology investigator group. Stillbirths: rates, risk factors, and acceleration towards 2030. Lancet. 2016 Feb 6;387(10018):587-603. doi: 10.1016/S0140-6736(15)00837-5. Epub 2016 Jan 19.
- van Eijk AM, Larsen DA, Kayentao K, Koshy G, Slaughter DEC, Roper C, Okell LC, Desai M, Gutman J, Khairallah C, Rogerson SJ, Hopkins Sibley C, Meshnick SR, Taylor SM, Ter Kuile FO. Effect of Plasmodium falciparum sulfadoxine-pyrimethamine resistance on the effectiveness of intermittent preventive therapy for malaria in pregnancy in Africa: a systematic review and meta-analysis. Lancet Infect Dis. 2019 May;19(5):546-556. doi: 10.1016/S1473-3099(18)30732-1. Epub 2019 Mar 25.
- Gonzalez R, Mombo-Ngoma G, Ouedraogo S, Kakolwa MA, Abdulla S, Accrombessi M, Aponte JJ, Akerey-Diop D, Basra A, Briand V, Capan M, Cot M, Kabanywanyi AM, Kleine C, Kremsner PG, Macete E, Mackanga JR, Massougbodgi A, Mayor A, Nhacolo A, Pahlavan G, Ramharter M, Ruperez M, Sevene E, Vala A, Zoleko-Manego R, Menendez C. Intermittent preventive treatment of malaria in pregnancy with mefloquine in HIV-negative women: a multicentre randomized controlled trial. PLoS Med. 2014 Sep 23;11(9):e1001733. doi: 10.1371/journal.pmed.1001733. eCollection 2014 Sep.
- Divala TH, Mungwira RG, Mawindo PM, Nyirenda OM, Kanjala M, Ndaferankhande M, Tsirizani LE, Masonga R, Muwalo F, Boudova S, Potter GE, Kennedy J, Goswami J, Wylie BJ, Muehlenbachs A, Ndovie L, Mvula P, Mbilizi Y, Tomoka T, Laufer MK. Chloroquine as weekly chemoprophylaxis or intermittent treatment to prevent malaria in pregnancy in Malawi: a randomised controlled trial. Lancet Infect Dis. 2018 Oct;18(10):1097-1107. doi: 10.1016/S1473-3099(18)30415-8. Epub 2018 Sep 5. Erratum In: Lancet Infect Dis. 2019 Feb;19(2):e39.
- Kimani J, Phiri K, Kamiza S, Duparc S, Ayoub A, Rojo R, Robbins J, Orrico R, Vandenbroucke P. Efficacy and Safety of Azithromycin-Chloroquine versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment of Plasmodium falciparum Malaria Infection in Pregnant Women in Africa: An Open-Label, Randomized Trial. PLoS One. 2016 Jun 21;11(6):e0157045. doi: 10.1371/journal.pone.0157045. eCollection 2016.
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- Madanitsa M, Kalilani L, Mwapasa V, van Eijk AM, Khairallah C, Ali D, Pace C, Smedley J, Thwai KL, Levitt B, Wang D, Kang'ombe A, Faragher B, Taylor SM, Meshnick S, Ter Kuile FO. Scheduled Intermittent Screening with Rapid Diagnostic Tests and Treatment with Dihydroartemisinin-Piperaquine versus Intermittent Preventive Therapy with Sulfadoxine-Pyrimethamine for Malaria in Pregnancy in Malawi: An Open-Label Randomized Controlled Trial. PLoS Med. 2016 Sep 13;13(9):e1002124. doi: 10.1371/journal.pmed.1002124. eCollection 2016 Sep.
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- Kajubi R, Ochieng T, Kakuru A, Jagannathan P, Nakalembe M, Ruel T, Opira B, Ochokoru H, Ategeka J, Nayebare P, Clark TD, Havlir DV, Kamya MR, Dorsey G. Monthly sulfadoxine-pyrimethamine versus dihydroartemisinin-piperaquine for intermittent preventive treatment of malaria in pregnancy: a double-blind, randomised, controlled, superiority trial. Lancet. 2019 Apr 6;393(10179):1428-1439. doi: 10.1016/S0140-6736(18)32224-4. Epub 2019 Mar 22.
- Desai M, Gutman J, Taylor SM, Wiegand RE, Khairallah C, Kayentao K, Ouma P, Coulibaly SO, Kalilani L, Mace KE, Arinaitwe E, Mathanga DP, Doumbo O, Otieno K, Edgar D, Chaluluka E, Kamuliwo M, Ades V, Skarbinski J, Shi YP, Magnussen P, Meshnick S, Ter Kuile FO. Impact of Sulfadoxine-Pyrimethamine Resistance on Effectiveness of Intermittent Preventive Therapy for Malaria in Pregnancy at Clearing Infections and Preventing Low Birth Weight. Clin Infect Dis. 2016 Feb 1;62(3):323-333. doi: 10.1093/cid/civ881. Epub 2015 Oct 20.
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- Tuikue Ndam N, Tornyigah B, Dossou AY, Escriou G, Nielsen MA, Salanti A, Issifou S, Massougbodji A, Chippaux JP, Deloron P. Persistent Plasmodium falciparum Infection in Women With an Intent to Become Pregnant as a Risk Factor for Pregnancy-associated Malaria. Clin Infect Dis. 2018 Nov 28;67(12):1890-1896. doi: 10.1093/cid/ciy380.
- Briand V, Cottrell G, Tuike Ndam N, Martianez-Vendrell X, Vianou B, Mama A, Kouwaye B, Houze S, Bailly J, Gbaguidi E, Sossou D, Massougbodji A, Accrombessi M, Mayor A, Ding XC, Fievet N. Prevalence and clinical impact of malaria infections detected with a highly sensitive HRP2 rapid diagnostic test in Beninese pregnant women. Malar J. 2020 May 24;19(1):188. doi: 10.1186/s12936-020-03261-1. Erratum In: Malar J. 2020 Sep 7;19(1):328.
- Tagbor H, Cairns M, Bojang K, Coulibaly SO, Kayentao K, Williams J, Abubakar I, Akor F, Mohammed K, Bationo R, Dabira E, Soulama A, Djimde M, Guirou E, Awine T, Quaye S, Njie F, Ordi J, Doumbo O, Hodgson A, Oduro A, Meshnick S, Taylor S, Magnussen P, ter Kuile F, Woukeu A, Milligan P, Chandramohan D, Greenwood B. A Non-Inferiority, Individually Randomized Trial of Intermittent Screening and Treatment versus Intermittent Preventive Treatment in the Control of Malaria in Pregnancy. PLoS One. 2015 Aug 10;10(8):e0132247. doi: 10.1371/journal.pone.0132247. eCollection 2015.
- Taylor SM, Madanitsa M, Thwai KL, Khairallah C, Kalilani-Phiri L, van Eijk AM, Mwapasa V, Ter Kuile FO, Meshnick SR. Minimal Impact by Antenatal Subpatent Plasmodium falciparum Infections on Delivery Outcomes in Malawian Women: A Cohort Study. J Infect Dis. 2017 Aug 1;216(3):296-304. doi: 10.1093/infdis/jix304.
- Dorman EK, Shulman CE, Kingdom J, Bulmer JN, Mwendwa J, Peshu N, Marsh K. Impaired uteroplacental blood flow in pregnancies complicated by falciparum malaria. Ultrasound Obstet Gynecol. 2002 Feb;19(2):165-70. doi: 10.1046/j.0960-7692.2001.00545.x.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月6日
初级完成 (估计的)
2025年12月1日
研究完成 (估计的)
2025年12月1日
研究注册日期
首次提交
2023年2月24日
首先提交符合 QC 标准的
2023年2月24日
首次发布 (实际的)
2023年3月7日
研究记录更新
最后更新发布 (估计的)
2024年1月24日
上次提交的符合 QC 标准的更新
2024年1月23日
最后验证
2024年1月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Pro00110771
- 1U01AI162463-01A1 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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