Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Development of sexual stages of P.falciparum
研究概览
简要总结
Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission.The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with or without PQ on the sexual and asexual stages of P. falciparum in Sumatra, Indonesia.
详细描述
The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.
The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.
Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.
All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 4 years old
- •parasite count ≥ 1,000 asexual parasites/µL
- •normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
- •hemoglobin level ≥ 8 gr/dL as measured by Hemoque® apparatus;
- •have the ability to return for 42-day-follow up and
- •willingness to sign the informed-consent form.
排除标准
- •are infected with other r plasmodium species
- •have only gametocytes of P. falciparum;
- •are pregnant - measured by positive result on HCG urine test and/or breastfeeding women
- •present signs of pitting edema on both legs as a sign of malnutrition
- •have complicated or severe malaria, other chronic diseases or history of drug allergies.
研究组 & 干预措施
dihydroartemisinin-piperaquine
干预措施: dihydroartemisinin-piperaquine (Drug)
Dihydroartemisininpiperaquine primaquine
干预措施: dihydroartemisinin-piperaquine + primaquine (Drug)
结局指标
主要结局
Development of sexual stages of P.falciparum
时间窗: 42 days post treatment
Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.
次要结局
- Clearance of asexual stages P.falciparum(42 days post treatment)