Malaria Infections and Infestations Malaria
Conditions
Interventions
Fixed dose combination (Intervention):
Artesunate/mefloquine fixed dose combination of artesunate 100 mg and mefloquine 200 mg tablets
Non fixed tablets/standard dose (Control):
Mefloquine 250 mg and
Sponsors
Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 to 65 years 2. Body weight at least 40 kg 3. Microscopically confirmed, monoinfection of P. falciparum (parasitaemia more than 2/200 White Blood Cell count [WBC]). Note: if vivax parasitaemia is detected after Day 0, patients will still be kept in the study and follow the schedule of investigations. 4. History of fever or presence of fever (axillary temperature more than 37.5°C) 5. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women 2. P. falciparum asexual stage parasitaemia more than 4% red blood cells (175,000/µl) 3. Clinical and/or lab features of severe malaria: 3.1. Impaired consciousness 3.2. Inability to eat and drink 3.3. Vomiting more than two episodes in preceeding 24 hours 3.4. Convulsions during present illness 3.5. Prostration 3.6. Severe anaemia (haematocrit [Hct] less than 20%) 3.7. Respiratory distress/pulmonary oedema 3.8. Shock 3.9. Spontaneous bleeding 3.10. Acute haemolysis with haemoglobinuria 3.11. Acute renal failure 3.12. Hyperbilirubinaemia (more than 3 mg/dL) 3.13. Hypoglycaemia 3.14. Acidosis 4. Baseline electrocardiogram (ECG) abnormality 5. Recent ingestion of mefloquine within previous 60 days 6. Contraindications to mefloquine 7. History of convulsions and/or psychiatric illnesses 8. Known hypersensitivity to artemisinins or mefloquine 9. Splenectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current information as of 01/12/2009: Pharmacokinetic parameters of both drug regimens. Initial information at time of registration: Day 63 PCR-adjusted cure rates of each treatment calculated using Kaplan?Meier survival analysis with log rank test for significance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 01/12/2009: 1. Time to fever 2. Time to parasite clearance 3. PCR corrected, day 28 cure rate Safety and tolerability endpoints: 1. Adverse events Initial information at time of registration: 1. Time to fever 2. Time to parasite clearance 3. Rates of appearance of vivax malaria during follow-up Safety and tolerability endpoints: 1. Incidence of anaemia 2. Other adverse events | — |
Countries
Thailand
Outcome results
None listed