Malaria
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: matriculation in the village school, age 6–13 years, absence of severe acute illness, ability to attend follow-up visits, written and expressed informed consent/assent from parent and student (10-13 years aged) respectively, and no history of allergy to study medications.
Exclusion criteria
Exclusion criteria: Not meeting all inclusion criteria or with a history of chronic disease were excluded from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was episodes of clinical malaria, defined by parasitemia detected in the setting of axillary temperature >37.5 °C and/or complaints of headache, vomiting or joint pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were asymptomatic parasitaemia, haemoglobin measurement, all-cause clinic visits and school performance as observed by their classroom teacher. In order to measure these endpoints, the team performed monthly follow up visits for the five months following the initial treatment dose. The follow up visit included history, physical examination, and finger-prick blood collection (parasitaemia and haemoglobin concentration measurement). Students received a second course of study medication 8-weeks after the initial course. In addition to the active monthly follow-up, participants were instructed that they should come to the clinic for any illness. All unscheduled visits by participants to the clinic during the study period were documented. Children presenting with signs and symptoms of malaria underwent thick and thin smears and haemoglobin testing. In year one, two and three, students with clinical malaria were treated with their IPTsc treatment. In the case of students in arm Control they received SP monotherapy in year one and were treated with artemether-lumefantrine (CoartemR) in years two and three. Cases of severe malaria, defined by World Health Organization (WHO) criteria in 2000, were treated with intra-venous (IV) quinine. Clinicians provided supportive care and treatment for all other diagnoses according to the national guidelines. | — |
Countries
Mali
Contacts
Biostatician to MRTC