Malaria Infections and Infestations Malaria
Conditions
Interventions
Artemether and lumefantrine six doses over three days orally (per os) according to manufacturer recommendations. As this is a surveilllance study there is no control group.
Contact details of Princip
Sponsors
World Health Organization (WHO) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All ages, 6 months and above 2. Single infection with P. falciparum 3. Parasitaemia of 1,000 - 100, 000 asexual forms per µl 4. Axillary temperature of 37.5°C or oral/rectal temperature of 38°C, or history of fever in the previous 24 hours 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 (SD) 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 (e.g. cardiac, renal, hepatic diseases, Human Immunodeficiency Virus [HIV]/Acquired Immune Deficiency Syndrome [AIDS]) 5. History of hypersensitivity reactions to any of the drug(s) being tested or used as alternative treatment 6. Pregnancy or positive pregnancy test or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the clinical and parasitological efficacy (Adequate Clinical and Parasitological Response [ACPR]). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To differentiate recrudescence from new infections by the Polymerase Chain Reaction (PCR) analysis 2. To measure the clinical and parasitological efficacy PCR corrected | — |
Countries
Eritrea
Outcome results
None listed