Malaria Infections and Infestations Malaria
Conditions
Interventions
Group A: Artesunate 10 mg/kg, rectal
Group B: Quinine 20 mg dihydrochloride salt/kg, intra-muscular injection (followed by 10 mg/kg at 12 and 24 hours)
Sponsors
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 3 to 24 months 2. Suspected malaria with no other obvious cause of illness 3. P. falciparum asexual parasitaemia greater than ++ (5 - 10 parasites/High Power Field [HPF]) 4. Unable to eat, suck or drink, or repeatedly vomiting (more than three episodes over past 24 hours); or prostrate (unable to sit or stand if previously able to do so) 5. History of convulsions over the preceding 24 hours or impaired consciousness (Blantyre Coma Score less than five) 6. Parent/guardian informed consent
Exclusion criteria
Exclusion criteria: 1. Ability to tolerate oral intake 2. Acute diarrhoea defined as the presence of more than three episodes of watery stools in the preceding 24 hours 3. History of allergy to artemisinin compounds and/or quinine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day disease-free survival, defined as patients who survived the 28-day period of follow-up with the peripheral blood free of the original genotype of malaria parasites. | — |
Secondary
| Measure | Time frame |
|---|---|
| The parasitological outcomes and tolerability of a single dose of the rectal artesunate in children aged 3 to 24 months with non per os falciparum malaria. | — |
Countries
Ghana, Tanzania
Outcome results
None listed