Randomized comparison of chloroquine and amodiaquine in the treatment of acute, uncomplicated, Plasmodium falciparum malaria in children

The increasing resistance of Plasmodium falciparum to chloroquine (CQ) has created an urgent need for the evaluation of alternative, effective, safe, cheap, readily available and affordable antimalarial treatments. In the pre sent study, the efficacy of amodiaquine (AQ) in the treatment of acute, sym ptomatic, uncomplicated, P. falciparum malaria was compared with that of CQ , each drug being given at 10 mg/ kg per day for 3 days (days 0, 1 and 2). The 210 subjects (104 given AQ and 106 CQ) were Nigerian children aged 5 mo nths-12 years. Fever-clearance times (FCT), parasite densities on days 1-4 and parasite-clearance times (PCT) were all significantly lower with AQ tha n with CQ. Mean (S.D.) PCT, for example, were 2.6 (0.8) days with AQ and 3. 0 (1.0) days with CQ (P = 0.001). The cure rates obtained on days 14, 21 a nd 28-98.1% v. 79.3% (P = 0.000), 97.1% v. 64.2% (P = 0.00001) and 95.2% v. 58.5% (P = 0.0000000) with AQ and CQ, respectively-were all also significa ntly higher with AQ. All but two of the 20 subjects who were considered CQ- treatment failures by day 14 (i.e. two RIII, two RII and 16 RI) responded t o subsequent treatment with AQ, with PCT (but not FCT) significantly shorte r than during their initial treatment with CQ. In siblings in whom there wa s clustering of infections, the cure rates were 100% with AQ (N = 12) and 6 3.6% with CQ (N = 11; P = 0.03). Adverse reactions to CQ and AQ were simila r and tolerable: pruritus in 10 and 11 children in the AQ and CQ groups, re spectively, and gastro-intestinal disturbances which occurred in three chil dren from each group. Haematological parameters were not adversely affected by either drug. At least in the setting of the present study, AQ appears more effective tha n CQ, effective against CQ-resistant infections, and well tolerated by chil dren with acute, uncomplicated, P. falciparum malaria. It may therefore be useful as an alternative to CQ in areas of CQ resistance.