IPT in Schoolchildren: Comparison of the Efficacy, Safety, and Tolerability of Antimalarial Regimens in Uganda
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 780
- 主要终点
- Risk of Parasitaemia (Unadjusted by Genotyping)
研究概览
简要总结
This will be a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety and tolerability of antimalarial regimens in healthy schoolchildren. The primary objective of the study is to compare the efficacy of different combination antimalarial regimens, including amodiaquine + sulfadoxine-pyrimethamine (AQ+SP), dihydroartemisinin-piperaquine (DP), and placebo, to SP for intermittent preventive treatment (IPT) in schoolchildren, as measured by risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up. This will assess both the efficacy for treatment of asymptomatic infections and the efficacy for prevention of new infections.
详细描述
The study will be carried out among children aged ≥ 8 to < 14 years (boys) and ≥ 8 to < 12 years (girls) attending primary schools in Tororo district. Schools will be selected using convenience sampling with the assistance of the district and the education sector. The target population includes children attending primary schools in Uganda. The accessible population includes the children attending the participating primary schools in classes 3-7 in Tororo district. Children who meet the selection criteria for participation in the study will be randomized to treatment with one of the four study regimens and will be followed for 42 days. Repeat evaluations will be performed on days 1, 2, 3, 7, 14, 28, and 42 (and any unscheduled day that a student is ill) and will include assessment for the occurrence of adverse events. Treatment efficacy outcomes will be assessed using revised WHO outcome classification criteria. Acceptability of treatment regimens will be assessed using a questionnaire administered to participating students on day 7. The primary outcome measure is risk of parasitaemia (unadjusted by genotyping) after 42 days of follow-up.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 8 to < 14 years (boys), ≥ 8 to < 12 years (girls)
- •Student enrolled at participating school in classes 3-7
- •Provision of informed consent from parent or guardian
- •Provision of assent by student
排除标准
- •Known allergy or history of adverse reaction to study medications
- •Onset of menstruation (girls)
- •Fever (≥ 37.5°C axillary) or history of fever in the previous 24 hours
- •Evidence of severe malaria or danger signs
- •Haemoglobin < 7.0 gm/dL
- •Parasite density > 10,000/ul
研究组 & 干预措施
Combination of Amodiaquine +sulfadoxine-pyrimethamine
Combination of Amodiaquine (Camoquin, Parke-Davis, 200 mg tablets, 10 mg/kg on days 0 and 1, and 5 mg/kg on day 2) + sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
干预措施: amodiaquine + sulfadoxine-pyrimethamine (Drug)
Dihydroartemisinin-piperaquine
Dihydroartemisinin-piperaquine (Duocotexin, Holley Pharm, 40 mg dihydroartemisinin/320 mg piperaquine tablets targeting a total dose of 6.4 and 51.2 mg/kg of dihydroartemisinin and piperaquine, respectively, given in 3 equally divided daily doses to the nearest ¼ tablet)
干预措施: dihydroartemisinin-piperaquine (Drug)
Placebo
Placebo (had no active ingredients, produced by Cosmos Limited, Nairobi, Kenya)
干预措施: Placebo (Other)
Sulfadoxine-pyrimethamine alone
sulfadoxine-pyrimethamine (Fansidar, Roche, 500 mg/25 mg tablets, 25 mg/kg sulfadoxine and 1.25 mg/kg pyrimethamine per treatment as a single dose) given as oral tablets
干预措施: sulfadoxine-pyrimethamine (Drug)
结局指标
主要结局
Risk of Parasitaemia (Unadjusted by Genotyping)
时间窗: after 42 days of follow-up
Proportion of participants whose thick blood smears that are positive for asexual parasites
次要结局
- Risk of Recrudescence (Adjusted by Genotyping) in Participants Who Were Parasitaemic at Enrollment(after 42 days of follow-up)
- Acceptability of IPT Regimens(on day 7)
- Risk of New Infection (Adjusted by Genotyping) in All Participants(after 42 days of follow-up)
- Risk of Clinical Failure Due to Recrudescence (Adjusted by Genotyping) in Children Who Were Parasitaemic at Enrollment(after 42 days of follow-up)
- Mean Change in Haemoglobin(Between day 0 to day 42)
- Risk of Serious Adverse Events(over 42 days of follow-up)
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine