A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 320
- 试验地点
- 2
- 主要终点
- The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
研究概览
简要总结
This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.
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
- 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 mono-infection or P. vivax / P. falciparum mixed infection
- •Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs
- •Able to tolerate oral medication
- •Able and willing to comply with the study protocol for the duration of the study
- •Informed consent from the patient or from a parent or guardian in the case of children
排除标准
- •Bodyweight ≤5kg
- •Presence of general danger signs in children aged under 5 years or signs of severe malaria in any patient 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
Pf: ASP
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP)
干预措施: ASP (Drug)
Pv: ASP + 14DPQ on day 2
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2
干预措施: ASP (Drug)
Pv: ASP + 14DPQ on day 2
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2
干预措施: 14DPQ (Drug)
Pf: ASP + SDPQ
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2
干预措施: ASP (Drug)
Pf: ASP + SDPQ
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2
干预措施: SDPQ (Drug)
Pv: ASP + 14DPQ on day 42
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42
干预措施: ASP (Drug)
Pv: ASP + 14DPQ on day 42
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42
干预措施: 14DPQ on Day 42 (Drug)
结局指标
主要结局
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
时间窗: In the first 42 days
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm
The recurrence of parasitaemia within 42 days of follow in P. vivax infections
时间窗: In the first 42 days
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm
次要结局
- The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment(on days 1,2,3)
- The proportion of patients with fever on day 1, 2 and 3 after treatment(on days 1, 2, 3)
- The fractional change in Hb between baseline and day 7,14 and 16 (incl. proportion of patients with >25% drop in Hb between the time points) in vivax / mixed infection patients receiving PQ(on days 0, 7, 14 and 16)
- The proportion of patients with gametocytemia on any of the follow up dates(In the first 42 days)
- The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment(In the first 42 days)
- The proportion of patients with adverse and serious adverse events(In the first 42 days)
- The distribution of G6PD activity among the study population(on day of enrolment)
- The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count(at the end of 14DPQ treatment (day 16))