PACTR202303630742194尚未招募3 期
Dihydroartemisinin-piperaquine and azithromycin for the post-discharge management of children with severe anaemia in Malawi, Kenya and Uganda; A, multicentre, parallel-group, two-arm, randomised, double-blind superiority trial
Training and Research Unit of Excellence0 个研究点目标入组 958 人开始时间: 2023年2月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 958
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1 Month(s) 至 23 Month(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria for enrolment into pre-study screening period
- •1.Haemoglobin <5.0 g/dl or PCV < 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
- •2.Aged less than 59.8 months
- •3.Body weight =5 kg
- •4.Resident in catchment area
- •Inclusion criteria for enrolment:
- •1.Fulfilled the pre-study screening eligibility criteria
- •2.Aged < 59.8 months
- •3.Clinically stable, able to take oral medication
- •4.participant completed blood transfusion(s) or became clinically stable without transfusion
- •5.Able to feed (for breastfeeding children) or eat (for older children)
- •6.Absence of known cardiac problems
- •7.Provision of informed consent by parent or guardian
- •Inclusion criteria for randomisation:
- •1.Fulfilled enrolment eligibility criteria and was enrolled during recent admission
- •2.Aged <60 months
- •3.Still clinically stable, able to take to oral medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so prior to hospitalisation)
排除标准
- •Exclusion criteria for enrolment into pre-study screening period
- •1.Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder).
- •2.Known sickle cell disease.
- •3.Anticipated to reach the 5th birthday (60 months of age) within 1 week from enrolment (i.e. prior to randomization).
- •4.Child will reside for more than 25% of the 6 months study period (i.e. 6 weeks or more) outside of catchment area.
- •5.Hereditary polymorphisms, other than sickle cell disease, that are known to provide protection against severe forms of malaria
- •6.Cotrimoxazole prophylaxis (usually due to HIV infection or exposure)
- •Exclusion criteria for enrolment:
- •1.Previous enrolment in the present study
- •2.Known hypersensitivity to study medication
- •3.Known sickle cell disease
- •4.Use or known need at the time of enrolment for concomitant prohibited medication during the 17 weeks intervention period
- •5.Ongoing or planned participation in another clinical trial
- •6.A known need at the time of enrolment for scheduled surgery during the subsequent course of the study (6 months from enrolment)
- •7.Suspected non-compliance with the follow-up schedule
- •8.Known heart conditions, or family history of congenital prolongation of the QTc interval.
- •9.Taking other medicinal products that are known to prolong the QTc interval
- •Exclusion criteria for randomisation:
- •1.Used AZ since enrolment
- •2.Use or known need at the time of randomisation for concomitant prohibited medication during the 16 weeks PDMC treatment period.
- •3.Enrolled, or known agreement to enrol into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months from enrolment)
- •4.A known need at the time of randomisation for scheduled surgery during the subsequent course of the study (6 months from enrolment)
- •5.Suspected non-compliance with the follow-up schedule
- •6.Withdrawal of consent since enrolment
研究者
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