Malaria/uncomplicated/resistance Infections and Infestations Plasmodium falciparum malaria
Conditions
Interventions
Patients will be randomised in blocks of 10 to receive either:
1. Artesunate (Guilin Pharmaceutical Company, PRC) orally (po) 2 mg/kg/day for 7 days
2. Artesunate (Guilin Pharmaceutical Company, PRC)
blood collection for parasitaemia during hospitalisation will stop when the patient is parasite negative).
Sampling (2 ml):
1. Parasite counts: 0, 4, 8, 12, 18, 24 hours then 6 hourly until parasite
Sponsors
University of Oxford (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 40 patients with uncomplicated falciparum malaria 2. Aged greater than or equal to 15 years, either sex 3. Symptomatic of malaria infection, i.e., history of fever or presence of fever greater than 37.5°C 4. Microscopic confirmation of asexual stages of P. falciparum with parasitaemia greater than 10,000/ml 5. Written informed consent to participate in trial
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation (urine test for beta-human chorionic gonadotropin [ß-HCG] to be performed on any woman of child bearing age unless menstruating) 2. P. falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175,000/µl) 3. History of treatment with antimalarials (except chloroquine [CQ] or sulfadoxine-pyrimethamine [SP]) in the previous 48 hours 4. Microscopy indicates a mixed infection 5. Signs or symptoms indicative of severe malaria: 5.1. Impaired consciousness (Glasgow Coma Scale [GCS] less than 15) 5.2. Bleeding disorder (severe nosebleed, bleeding gums, frank haematuria, bleeding from venepuncture sites) 5.3. Respiratory distress (deep breathing or respiratory rate [RR] greater than 30) 5.4. Shock (circulatory collapse with systolic blood pressure [SBP] less than 80 mmHg) 5.5. Hyperparasitaemia (see above) 5.6. Acidosis (bicarbonate [HCO3-] less than 15 mmol/L) 5.7. Renal insufficiency (creatinine greater than 3 mg/dL) 5.8. Severe jaundice (total bilirubin greater than 2.5 mg/dL) 5.9. Severe anaemia (haematocrit [Hct] less than 20% in adults or less than 15% in children) 5.10. Severe hypoglycaemia (glucose less than 40 mg/dL) 6. Known hypersensitivity to artemisinin derivatives or mefloquine 7. History of convulsions or neuropsychiatric disorder 8. History of splenectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A population based pharmacokinetic-pharmacodynamic modelling approach will be used to describe the antimalarial effect of artesunate in patients with acute falciparum malaria. The objective of the modelling exercise is to characterise the relationship between pharmacokinetic variables (areas under curve [AUC], Cmax) and parasite clearance measures (parasite clearance time [PCT], parasite reduction ratio [PRR]), completed with in vitro susceptibility and molecular markers of resistance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Parasitological efficacy | — |
Countries
Thailand
Outcome results
None listed