Intermittent Preventive Therapy Post-Discharge: an innovative approach in the prevention of rebound severe malaria anaemia and mortality in young children - a randomised double-blind placebo controlled multicentre study

iverpool School of Tropical Medicine (UK)0 个研究点目标入组 1,650 人开始时间: 2006年6月19日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Haemoglobin <5.0 g/dl or packed cell volume (PCV) <15% on admission to the hospital
•2. Plasmodium falciparum malaria (any documented parasitaemia) at the time of admission to the hospital or within 24 hours prior to admission
•3. Aged between 4 months (inclusive) and 59 months (inclusive) at the time of randomization
•4. Bodyweight >5 kg at the time of randomization
•5. Subject completed blood transfusion(s) in accordance with routine hospital practice
•6. Subject completed intravenous (IV) quinine in accordance with routine hospital practice
•7. Able to feed (for breastfed children) or eat (for older children)
•8. Able to sit unaided
•9. Provision of informed consent by parent or guardian

•1. Recognised, specific other cause of severe anaemia at the time of admission to the hospital (e.g. trauma, haematological malignancy, known bleeding disorder, known sickle cell disease)
•2. Previous enrolment in the present study
•3. Severe anaemia (haemoglobin <5.0 g/dl ) at the time of randomization
•4. Known hypersensitivity to any of the study drugs
•5. Documented intake of Coartem® (=4 doses) or SP within 1 week prior to admission
•6. Child resides outside of catchment area during the course of the study (6 months)
•7. Known need at the time of randomization for concomitant prohibited medication during the 2 months randomized treatment period
•8. Ongoing participation into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months)
•9. Known need, or scheduled surgery during the course of the study (6 months)
•10. Suspected non-compliance with the follow-up schedule

发起方

iverpool School of Tropical Medicine (UK)