Post-discharge Malaria Chemoprevention(PMC) Study

Exclusion Criteria

• •Pre-study screening
• •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 2 weeks 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 Enrolment in study (t=0)
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• •1. Previous enrolment in the present study
• •2. Known hypersensitivity to study drug
• •3. Sickle cell disease
• •4. Use or known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
• •5. Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the course of the study (6 months from enrolment)
• •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. Know heart conditions, or family history of congenital prolongation of the QTc interval.
• •9. Taking medicinal products that are known to prolong the QTc interval Randomisation (t=2 weeks)
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• •1. Used dihydroartemisinin since enrolment
• •2. Use or known need at the time of randomisation for concomitant prohibited medication during the 14 weeks PMC 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