Malaria
Conditions
Interventions
Sponsors
Armauer Hansen Research Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age between six months and older 2. Monospecific infestation with P. falciparum detected by microscopic examination parasitemia between 500 and 200,000/µl (asexual parasite forms) 3. Axillary temperature =37.5°C or history of fever in the last 24 hours; ability to take oral medications 4. Ability and willingness to adhere to the protocol for the duration of the study and to respect the consultation schedule 5. Informed consent of the patient, or the parent or guardian, in the case of children under the age of majority in that country and informed consent of all minor participants over the age of twelve and under the age of majority in that country
Exclusion criteria
Exclusion criteria: 1. Presence of general danger signs in children under 12 years of age or signs of severe P. falciparum malaria as defined by WHO. 2. Body weight less than 5 kg; 3. Hemoglobin < 8 g/dl; mixed or monospecific infestation with another species of Plasmodium, detected by microscopic examination 4. Severe malnutrition defined as a child aged 6-60 months with a mid-upper arm circumference <115 mm) 5. Febrile illness due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, a severe diarrheal disease with dehydration) or other known chronic or serious underlying diseases (e.g. heart, kidney or liver disease, HIV/AIDS); 6. Regular use of medication, which may interfere with the pharmacokinetics of the antimalarial drug; history of hypersensitivity to, or contraindication to, any of the drugs tested or used as an alternative therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adequate clinical and parasitological response | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To differentiate between recrudescence and new infection using polymerase chain reaction (PCR) analysis. 2. To assess the incidence of adverse events. 3. To determine the polymorphism of artemisinin resistance molecular markers. | — |
Countries
Djibouti
Contacts
Public ContactFitsum Tadesse
Lead Scientist at Armauer Hansen Research Institute
Outcome results
None listed