A comparative clinical trial of artemether and quinine in children with severe malaria.

ABSTRACT

OBJECTIVE: To compare the efficacy of artemether and quinine in the treatment of severe malaria in hospitalized children. STUDY DESIGN: Open randomized trial. SETTING: Pediatric ward of a tertiary care center. METHODS: All children admitted with clinical manifestations of severe malaria (as per WHO criteria) and asexual forms of Plasmodium falciparum demonstrated on peripheral smear were randomized to receive either artemether or quinine. Their clinical status and smears for parasite count were assessed every 12 hours until two successive blood films were negative. The primary end point of the study was death in the hospital and residual damage to the organ involved. The secondary end points were clearance of parasites and fever, length of time of recovery from coma and normal functions of the involved system. RESULTS: Forty-six cases completed the study protocol, 23 assigned to each drug group. Cerebral malaria was the commonest manifestation (76.1%). Mean age in artemether versus quinine group (6.6 +/- 3.5 and 5.8 +/- 2.4 years) as well as degree of parasitemia at admission (55,800 and 60,300 per microlitre) were comparable. The overall mortality rate was 23.9% with no significant difference between the two groups. Twenty six cases (56.5%) presented with more than one manifestations of severe malaria. The mortality rate was 100% with four coexisting manifestations of severe malaria. Fever clearance time in artemether and quinine group was 44.5 and 45.9 hours respectively (P >0.05). Parasite clearance time was significantly shorter in artemether group (40.9 vs. 51.9 hours; P<0.001). Recovery from coma was shorter in artemether group (34.8 vs. 38.1 hours; P<0.05). CONCLUSION: Cerebral malaria is the most common manifestation of severe malaria in children. Artemether is a good alternative drug to quinine for P. falciparum malaria. Mortality rate is directly proportional to the number of coexisting manifestations of severe malaria.