A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of Glucose-6-dehydrogenase Status in South-east Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 181
- 主要终点
- The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
研究概览
简要总结
This is a study assessing safety and efficacy of current national guidelines for the treatment of uncomplicated malaria in Bangladesh as well as to assess the G6PD status among the enrolled patients.
详细描述
The national guidelines for the treatment of uncomplicated malaria in Bangladesh currently recommend a standard dose of artemether-lumefantrine followed by a single dose of primaquine for P. falciparum malaria and a three day course of chloroquine followed by 14 days of primaquine for vivax malaria.Currently the national treatment guidelines do not include any testing for G6PD deficiency before treatment with primaquine. In order to guarantee safe and efficacious treatment for all patients diagnosed with uncomplicated malaria in Bangladesh, it is essential to monitor the effectiveness and safety of the recommended treatment guidelines. This trial therefore evaluates the local efficacy and safety of the current first line treatment and assesses the G6PD status of the enrolled patients.
Patients with uncomplicated malaria attending the health care center, who meet the study inclusion criteria will be enrolled, treated on site and followed up for 28 days. The follow-up will consist of a fixed schedule of check-up visits and corresponding clinical and laboratory examinations. The study will provide efficacy data for both artemether-lumefantrine and chloroquine and will generate data on G6PD status in the region, which will provide vital information for policy makers in regards to the wider roll out of primaquine for the radical cure of vivax malaria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 12 months
- •P. vivax or P. falciparum monoinfection or P.v. / P.f. mixed infection
- •Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
- •Ability to swallow oral medication.
- •Ability and willingness to comply with the study protocol for the duration of the study
- •Informed consent/assent from the patient or from a parent or guardian in the case of children.
排除标准
- •Presence of general danger signs in children aged under 5 years or signs of severe malaria according to the definitions of WHO
- •Presence of severe malnutrition
- •Acute anaemia <8g/dL
- •Regular medication, which may interfere with antimalarial pharmacokinetics
- •History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s)
- •A positive pregnancy test or lactating
研究组 & 干预措施
chloroquine primaquine 14days
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
干预措施: chloroquine (Drug)
chloroquine primaquine 14days
P.vivax malaria patients receiving chloroquine and primaquine 14days as per guidelines
干预措施: Primaquine (Drug)
artemether-lumefantrine primaquine 1day
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
干预措施: Artemether-lumefantrine combination (Drug)
artemether-lumefantrine primaquine 1day
P.falciparum malaria patients receiving artemether-lumefantrine combination and primaquine 1day as per guidelines
干预措施: Primaquine (Drug)
artemether-lumefantrine primaquine 14days
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
干预措施: Artemether-lumefantrine combination (Drug)
artemether-lumefantrine primaquine 14days
mixed malaria infection receiving artemether-lumefantrine combination and primaquine 14days as per guidelines
干预措施: Primaquine (Drug)
结局指标
主要结局
The Proportion of Adverse and Serious Adverse Events Following Unsupervised Primaquine Treatment
时间窗: during follow up (day 28)
The proportion of adverse and serious adverse events following unsupervised primaquine treatment until day 28
次要结局
- Proportion of Patients With Any Parasitemia on Day 3 After Treatment(day 3)
- Proportion of Patients Adhering to 14 Days of Primaquine Treatment in the Vivax Cohort as Measured by Pill Count(day 16)
- The Distribution of G6PD Activity Measured in U/gHb Among All Malaria Patients(day 0)
- Proportion of Patients With Anaemia Less Than 8g/dl on Day 2(on day 2)
- Proportion of Patients Receiving Blood Transfusion and With Severe Anaemia (Hb<7g/dl)(day 28)
- Fractional Change in Hb Between Baseline and Day 9 and 16(day 0 and 16)
- Proportion of Patients With Fever on Day 2 After Treatment(day 2)
- Recurrence of Parasitaemia Within 16 Days of Follow up(day 16)
- Frequency and Type of Variants of the G6PD Gene Within the Study Population(day 0 or 1)