Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,295
- 试验地点
- 1
- 主要终点
- The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children
研究概览
简要总结
Intermittent preventive treatment (IPT) offers a way of preventing malaria infection without compromising the development of malaria immunity or encouraging drug resistance. The effect of IPT in children in the prevention of malaria has been evaluated in a number of trials in areas of seasonal malaria transmission. Results from these trials have shown that IPTc provided between 40% - 86% protection against clinical malaria. In 2006, a trial that compared two methods of IPTc delivery was carried out in Upper River Division, The Gambia. Preliminary results of the trial have shown that the treatment was very effective as only 4% (45/1133) of the children seen at the end of year cross-sectional survey were parasitaemic. Tolerability was assessed in a subset of 1100 children and the results showed that about 13.5% of children developed mild to moderate vomiting. Malaise was present in about 10% of the study subjects. Severe adverse events were rare. Thus it is important to investigate if other drug regimens might be equally effective in preventing malaria but less likely to cause adverse events. During the 2007 malaria transmission season, 1009 children aged 1-5 years will be individually randomized to receive amodiaquine plus SP, piperaquine plus SP or Artekin TM (dihdroartemisinin plus piperaquine) at monthly intervals on three occasions during the months of September, October, and November. To determine the prevalence of side effects following drug administration participants in each treatment group will be visited at home three and seven days after each round of drug administration and a side effects questionnaire completed. To help establish whether these adverse events are drug related, the same questionnaire will be administered after each treatment round, to 286 age-matched children who are not part of the trial. The primary ends points will be the incidence of adverse events.
详细描述
Objectives
Primary Objective To determine the safety and tolerability of amodiaquine(AQ) (three days) plus sulfadoxine-pyrimethamine(SP) (one day), piperaquine(PQP) (three days) plus SP (one day), and Artekin TM (PQP plus dihydroartemisinin, DHA) (3 days) when used for seasonal IPT in children.
Secondary Objective To determine the efficacy of AQ (three days) plus SP (one day), PQP (three days) plus SP (one day) and Artekin TM (3 days) when used for seasonal IPT in children.
3.4 Randomisation Open-label, individual randomisation was carried out three weeks before the first dose of IPTc administration in September 2007. Study subjects were individually randomised into either the AQ plus SP, PQP plus SP or ArtekinTM treatment groups in a 1:1:1 fashion. An independent statistician generated the randomizing subject study number (SSN) that assigned each SSN to one of the treatment groups. A photo ID card was given to all participants to facilitate identification at every contact, at home or in the health centres.
3.5 Drug distribution at the health centres Study subjects and their parents were informed about the date of treatment approximately one week before any intervention. Treatment is scheduled to be given during the months of September, October and November. Drugs are to be given at the nearest health centre by a designated member of staff. Tablets are crushed, mixed with honey or suspended in water and given on a spoon. Staff who administer drugs at the health centre play no further part in the trial. All participants are kept under observation for 30 minutes after drugs are taken. In case of vomiting, the drug is re-administrated. At the time of each monthly drug administration, a brief clinical assessment is carried out. Children who are febrile are screened for malaria using a rapid antigen test. Children found to have malaria are treated with Lumefantrine-artemether (CoartemTM, Norvatis Pharma., Basel Switzerland).
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
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 1 to 5 years at enrolment.
- •Informed consent obtained from parents or legal guardians.
- •No current participation in another malaria intervention trial.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Available for the duration of the study.
排除标准
- •Known allergy to any of the antimalarial drugs used in the trial and if this is unknown, then a history of allergic reaction to any drug.
- •Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory tests.
研究组 & 干预措施
1
SP+AQ
干预措施: SP, amodiaquine, piperaquine, dihdroartemisinin (Drug)
2
Piperaquine plus SP arm
干预措施: intermittent preventive treatment (Drug)
3
Du-Cotecxin
干预措施: Du-Cotecxin (Drug)
结局指标
主要结局
The safety and tolerability of AQ plus SP, PQP plus SP, and PQP plus DHA when used for seasonal IPT in children
时间窗: Onset of IPT to end of malaria season
次要结局
- The efficacy of the three drug regimens when used for seasonal IPT in children(Onset of IPT to end of malaria season)
研究者
Brian Greenwood
Professor
London School of Hygiene and Tropical Medicine