Monitoring Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium Vivax Based on Clinical, Parasitologic and Hematologic Parameters in Shecha Health Center: Open Label Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Late Clinical Failure (LCF)
研究概览
简要总结
The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia.
The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter.
Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria.
This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.
详细描述
The goal of this open label clinical trial will be to assess the therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia. The main question it aims to answer:- the current therapeutic efficacy of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax in Shecha Health Center, South Ethiopia based on clinical, parasitological and hematological parameter.
Participants will be patients aged >6 months with diagnosis of plasmodium vivax mono-infection and who fulfills the inclusion criteria.
This is a single arm open label invivo therapeutic efficacy study of chloroquine plus primaquine in the treatment of uncomplicated plasmodium vivax. The final result will be compared with World Health Organization recommendation on antimalarial drug therapeutic efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 6 months
- •Slide confirmed infection with P. vivax with > 250 asexual forms/μl
- •Lives within 5 km of the enrolling health facility
- •Weight ≥ 5.0 kg
- •Ability to swallow oral medication
- •Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
- •Informed consent from patient or from a parent or guardian in the case of children
排除标准
- •Sever malaria with complication sign and symptoms
- •Signs or symptoms of severe malnutrition, defined as weight-for-age ≤ 3 standard deviations below the mean, symmetrical edema involving at least the feet, or mid-upper arm circumference <100 cm for children less than five years of age
- •Mixed plasmodium infection
- •Severe anemia, defined as hemoglobin (Hb) < 5 g/dl
- •Presence of febrile conditions caused by diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration)
- •Serious or chronic medical condition (e.g. cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
- •Positive pregnancy test or breastfeeding
- •Unable or unwilling to take contraceptives for women of child-bearing age
- •Children weighing less than 5 kilograms
- •History of hypersensitivity reaction to any medication tested or used as an alternative treatment
- •Participants with history of prolonged QT conditions
- •Taking regular medication, which may interfere with antimalarial pharmacokinetics or efficacy
研究组 & 干预措施
Therapeutic Efficacy of Chloroquine Plus Primaquine
An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg.
Primaquine - it was given once a day (0.25 mg/kg) for fourteen days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg.
The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
干预措施: Chloroquine (Drug)
Therapeutic Efficacy of Chloroquine Plus Primaquine
An invivo single arm trial. Chloroquine (tablet containing 150mg of base) - it was given on days 0 (10mg/kg), 1(10mg/kg) and 2 (5mg/kg). Total dose, 25 mg base/kg.
Primaquine - it was given once a day (0.25 mg/kg) for fourteen days, starting on day 0 of CQ treatment. Total dose, 3.5mg/kg.
The medications were administered under direct observation and the patient was monitored for vomiting for 60 minutes.
干预措施: Primaquine (Drug)
结局指标
主要结局
Late Clinical Failure (LCF)
时间窗: 42 days
Danger signs or severe malaria in the presence of parasitemia on any day between day 4 and 42 in patients who did not previously meet any of the criteria of Early Treatment Failure; Presence of parasitemia on any day between 4 and day 42 with axillary temperature ≥37.5 °C (or history of fever) in patients who did not previously meet any of the criteria of Early Treatment Failure.
Adequate Clinical and Parasitological Response (ACPR)
时间窗: 42 days
Absence of parasitemia on day 42 irrespective of axillary temperature, in patients who did not previously meet any of the criteria of Early Treatment Failure, Late Clinical Failure, or Late Parasitological Failure.
Early treatment failure [Time Frame: within the first 3 days]
时间窗: within the first 3 days
Danger signs or severe malaria on day 1, day 2 or day 3 in the presence of parasitemia;Parasitemia on day 2 higher than on day 0, irrespective of axillary temperature;Parasitemia on day 3 with axillary temperature ≥37.5 ºC;Parasitemia on day 3 ≥25% of count on day 0.
Late Parasitological Failure (LPF)
时间窗: 42 days
Presence of parasitemia on any day between day 7 and day 42 and axillary temperature \<37.5 ºC in patients who did not previous meeting any of the criteria of Early Treatment Failure or Late Clinical Failure.
次要结局
- The secondary outcome of this study is evaluating the incidence of adverse events in 42 follow-up period.(42 days)
- The secondary outcome of this study is determining fever clearance rate based on fever clearance time.(42 days)
- The secondary outcome of this study is determining mean hemoglobin change overtime in the 42 days study period.(42 days)
- The secondary outcome of this study is determining parasite clearance rate based on parasite clearance time.(42 days)
- The secondary outcome of this study is determining gametocyte clearance rate based on gametocyte clearance time.(42 days)
研究者
Dinka Dugassa
Principal Investigator
Wollega University