Plasmodium Falciparum Artemisinin Resistance Vietnam

General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.

Specific objectives

• To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
• To determine the efficacy of DHA-PPQ at day 42 post-treatment.
• To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
• To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;

Inclusion criteria

• Age: from 6 months of age;
• Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
• Mono-infection with P.falciparum with parasite density between 500-100,000/µl
• Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.

Exclusion criteria

• Mixed malaria infection;
• Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
• Concomitant acute illness necessitating specific treatment (antibiotics);
• Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
• Severe malnutrition;
• Danger signs:

• not able to drink
• incontrollable vomiting
• recent history of convulsions (>1 in 24 hours)
• unconscious state; neurological impairment
• unable to sit or stand
• Signs of severe malaria:

• Cerebral malaria (unrousable coma)
• Severe anaemia (Htc< 15%)
• Renal failure (serum creatinine > 3 mg/dL)
• Pulmonary oedema;
• Hypoglycemia (<40mg/dL)
• Shock (systolic BP < 70 mmHg in adults, 50 in children)
• Spontaneous bleeding
• Repeat generalized convulsions
• Macroscopic haemoglobinuria
• Severe jaundice
• Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing