Effectiveness and Safety of Intermittent Preventive Treatment for Malaria Using Either Dihydroartemisinin-piperaquine or Artesunate-amodiaquine in Reducing Malaria Related Morbidities and Improving Cognitive Ability in School-aged Children in Tanzania (InSMART-school)
Malaria,Falciparum, Anemia
About this trial
This is an interventional prevention trial for Malaria,Falciparum focused on measuring Malaria, school children, randomized controlled trial, safety, effectiveness, Dihydroartemisinin-piperaquine, cognitive, Artesunate-amodiaquine, malaria serology, drug resistance
Eligibility Criteria
Inclusion Criteria:
- Includes parental/guardian informed consent
- Assent by primary school children aged 11 years and above.
- Aged 5-15 years.
- Currently, lives within the pre-defined catchment area of Muheza District.
- Will remain within the same area throughout the study period (preferably class five and below).
Exclusion Criteria:
- Students at class 6 and 7
- Currently enrolled in another study or participated in another investigational drug study within the last 30 days.
- Known to have heart disease or a known cardiac ailment.
- Reports known hypersensitivity to the study drugs.
- Not willing to undergo all study procedures including physical examination and to provide blood samples as per this study protocol.
- Having clinical features of severe anaemia
- Febrile due to non-malaria illness at the time of recruitment.
- Has apparent severe infection or any condition that requires hospitalization
- Illness or conditions like hematologic, cardiac, renal, hepatic diseases which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency and SS sickle cell.
- Body weight < 14 k
Sites / Locations
- National Institute for Medical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
No Intervention
DP
ASAQ
Control
Dihydroartemisinin-piperaquine (DP), antimalarial drug to be given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects.
Artesunate-amodiaquine (ASAQ), antimalarial drugs to be given every 4 months 3 rounds for the first year. A second non-interventional year will assess possible rebound effects.
No intervention drugs will be given, but normal routine standard of care will be provided.