Malaria Infections and Infestations Malaria
Conditions
Interventions
Fixed dose coformulation (intervention):
Once a day for three days - target dose of mefloquine is 8 mg/kg/day and for artesunate is 4 mg/kg/day using paediatric tablets 25/50 mg artesunate/mefloquine
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age more than six months, either sex 2. Minimum weight of 5 kg 3. Microscopically confirmed mono or mixed infection of P. falciparum (asexual falciparum parasitaemia more than 5/500 White Blood Cell [WBC] count) 4. History of fever or presence of fever (tympanic or axillary temperature more than 37.5°C) 5. Written informed consent to participate in trial
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. P. falciparum asexual stage parasitaemia more than 4% red blood cells (175,000/µL) 3. Clinical features of severe malaria: impaired consciousness, inability to drink or breast feed, convulsions during the present illness, prostration, severe anaemia, respiratory distress, shock, spontaneous bleeding, acute haemolysis with haemoglobinuria 4. Other significant illnesses or signs e.g. severe jaundice, liver disease, renal disease, severe malnutrition 5. Recent ingestion of mefloquine within previous 60 days 6. Contraindications to mefloquine - history of convulsions and/or neuropsychiatric illnesses 7. Known hypersensitivity to artemisinins or mefloquine 8. Splenectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Parasitological cure 2. Adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tolerability and safety of drugs defined as incidence of adverse events within 28 days of follow up 2. Haematological recovery during 63 days of follow up 3. Incidence of Plasmodium vivax infection during 63 days of follow up 4. Prevalence of gametocytaemia during 63 days of follow up 5. Description of population pharmacokinetic profile of mefloquine and artesunate during 63 days of follow up | — |
Countries
Thailand
Outcome results
None listed