Active Surveillance for P. Falciparum Drug Resistance With Assessment of Transmission Blocking Activity of Single Dose Primaquine in Cambodia
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinical efficacy of DP
研究概览
简要总结
This is a two-arm, open label Treatment Study comparing the efficacy, safety, tolerability and pharmacokinetics of a three-day course of Dihydroartemisinin-Piperaquine (DP) with or without single-dose primaquine in patients with uncomplicated Plasmodium falciparum malaria. On the last day of DP therapy, volunteers will be randomized to receive either a single 45 mg dose of primaquine (PQ) or DP treatment only (no primaquine).
详细描述
Volunteers with uncomplicated malaria in Cambodia will be enrolled to current standard of care therapy with DHA-piperaquine to monitor therapeutic efficacy and measure resistance. The cardiac safety of piperaquine will be monitored with electrocardiograms during the treatment period. Resistance to DP and DP-PQ will be assessed by a combination of clinical, pharmacologic, and parasitologic parameters including genomic signatures of selection during careful weekly follow-up visits for 42 days. Volunteers will be randomized on day 3 to either a single 45mg dose of primaquine or no sexual stage therapy to evaluate effects of primaquine on the sexual stages of malaria (gametocytes) and potential transmissibility of infection to Anopheles mosquitoes as compared to those not treated with primaquine.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer with uncomplicated P. falciparum malaria (volunteers with mixed P. falciparum and P. vivax infections may be enrolled), 18-65 years of age
- •Baseline asexual parasite density between 1,000-200,000 parasites/uL
- •Able to provide informed consent
- •Available and agree to follow-up for anticipated study duration including 3 day treatment course at the MTF and weekly follow-up for the 42-day period
- •Authorized by local commander to participate if active duty military
排除标准
- •Allergic reaction or contraindication to DHA, piperaquine or primaquine
- •Significant acute comorbidity requiring urgent medical intervention
- •Signs/symptoms and parasitological confirmation of severe malaria
- •Use of any anti-malarial within the past 14 days.
- •Class I or II G6PD deficiency (defined as severe) as determined at screening
- •Pregnant or lactating female, or female of childbearing age, up to 50 years of age, who does not agree to use an acceptable form of contraception during the study
- •Clinically significant abnormal EKG, including a QTcF interval > 500 ms at enrollment.
- •Known or suspected concomitant use of QTc prolonging medications.
- •Judged by the investigator to be otherwise unsuitable for study participation
研究组 & 干预措施
DHA-piperaquine with Primaquine
3-day treatment course of DHA-piperaquine with 45mg single dose primaquine
干预措施: DHA-piperaquine and Primaquine (Drug)
DHA-piperaquine without Primaquine
3-day treatment course of DHA-piperaquine
干预措施: DHA-piperaquine and Primaquine (Drug)
结局指标
主要结局
Clinical efficacy of DP
时间窗: 3 years
Efficacy rates at 42 days (with 95% confidence intervals) for DP with and without single dose primaquine for uncomplicated P. falciparum diagnosed by positive PCR-corrected malaria microscopy.
次要结局
- Efficacy of Primaquine to treat sexual stage gametocyte infection and prevent transmission of P. falciparum gametocytes to mosquitoes.(3 years)
研究者
David Saunders
David Saunders, LTC, MC, USA
Armed Forces Research Institute of Medical Sciences, Thailand