Treatment of non-complicated malaria in children aged 2 to 10 years old Infections and Infestations
Conditions
Interventions
This is a single-arm trial, in which a sample of children with non-complicated malaria is given artemether-lumefantrine (6 doses/3 days) and followed over time to observe their response to the drug. T
Sponsors
Hospital Pediátrico David Bernardino - Dr. Luís Bernardino
Eligibility
Sex/Gender
All
Age
2 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. Children =2, =10-year-old, both sexes. 2. Body weight. We assume the upper 50% quartile (WHO child growth reference, WHO http:// www.who.int/childgrowth/standards/weight_for_age/en/) for inclusion, i.e. =9 Kg, with no evidence of severe sub-nutrition. 3. Plasmodium falciparum non-complicated malaria defined by axillar temperature =37.5°C (oral/rectal/tympanum =38°C) + microscopically confirmed Plasmodium falciparum parasitemia >1,000 =200,000 parasites/µL. 4. Written informed consent by the Patient’s Guardian. 5. Capacity to swallow medication. 6. Absence of antimalarial exposure during the last two weeks. 7. Having residence inside the CISA Demographic Survey Project
Exclusion criteria
Exclusion criteria: 1. Symptoms of severe malaria, requesting specific parental treatment, in accordance with WHO guidelines. 2. Oral treatment intolerance, including gastro-intestinal events (e.g. repeated vomiting or severe diarrhea) incompatible with an adequate drug absorption. 3. Clinical History or recent events of potentially confounding acute or chronicle conditions. 4. Anaemia at arrival (Hb <7g/dL) 5. Fever caused by conditions other than malaria. 6. Documented hyper-sensitivity to lumefantrine and artemisinin compounds. 7. Treatment with antimalarial in the last two weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of PCR-corrected recrudescent infections among 2–10-year-old patients with P. falciparum non-complicated malaria by day 28 post-treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The PCR-corrected efficacy (per protocol) values by day 42 2. PCR corrected reinfection rates by day 42 | — |
Countries
Angola
Outcome results
None listed