Malaria Infections and Infestations Malaria
Conditions
Interventions
Each patient will receive both:
1. Artemether-lumefantrine six consecutive doses according to manufacturer recommendation over three days orally (per os)
2. Artesunate 12 mg/kg over three days per os
Sponsors
World Health Organization (WHO)/HIV/AIDS, Tuberculosis and Malaria (HTM) - Global Malaria Programme
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged over 6 months old 2. Infection with P. falciparum 3. Parasitaemia, 1000 - 100 000 asexual forms per µl 4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C 5. Ability to swallow oral medication 6. Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule 7. Informed consent from the patient or from a parent or guardian in case of children
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs among children less than 5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions 2. Mixed or mono-infection with another Plasmodium species 3. Presence of severe malnutrition (defined as a child whose weight-for-height is below -3 standard deviation or who has symmetrical oedema involving at least the feet) 4. Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhoea with dehydration, etc.), or other known underlying chronic or severe diseases 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate clinical and parasitological response Polymerase Chain Reaction (PCR) corrected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events. | — |
Countries
Sudan
Outcome results
None listed