ABSTRACT
To evaluate the comparative efficacy and safety of artemether-lumefantrine [AL], artesunate-amodiaquine [ASAQ] and artesunate-amodiaquine-chlorpheniramine [AQC] for the treatment of acute uncomplicated malaria among Southwest Nigerian children. One hundred and sixty children aged 6 months to 14 years with acute uncomplicated malaria were randomized to AL [n = 53], ASAQ [n = 53], or AQC [n = 54]. Enrollees were seen daily on days 0-3 and then on days 7, 14, 21, 28 and 42 for clinical and parasitological evaluations. Paired samples of genomic DNA at enrolment and at the time of recurrent parasitaemia were genotyped using nested PCR to distinguish between reinfection and recrudescence. Detailed haematological and biochemical evaluations were carried out in a subset of enrollees on days 0, 7 and 28 as part of a safety evaluation. Of the 160 children, 144 [90%] completed the study. The mean fever clearance times and parasite clearance times for AL, ASAQ and AQC were comparable [p = 0.94 and p = 0.122, respectively]. On day 14, the adequate clinical and parasitological response [ACPR] for AL and AQC was 100% and for ASAQ it was 90% [p = 0.39]. The PCRuncorrected results on days 28 and 42 and the ACPR-corrected results on day 42 were similar for all drugs [p = 0.62 and p = 0.56, respectively]. AQC resulted in the best parasite clearance and haematological recovery on day 2 [p = 0.022 and p = 0.018, respectively]. Biochemical parameters were not adversely affected by the three artemisinin-based combination therapies [ACTs] and these were well tolerated. The three ACTs were efficacious and safe, but AQC resulted in a better haematological recovery on day 2 and higher cure rates throughout the study period
ABSTRACT
To evaluate the comparative efficacy of amodiaquine [AMQ] alone and the combination of AMQ and chlorpheniramine [CP] in the treatment of acute uncomplicated malaria in children. Of the 110 children enrolled in the study, 103 with acute uncomplicated malaria, aged 6 months to 12 years, were evaluated using the 14-day modification of the WHO field test. The patients were randomized to 2 groups. Group 1 received supervised treatment with AMQ alone [10 mg AMQ base/kg daily for 3 days], while group 2 received supervised treatment with AMQ [same dose as group 1] plus CP [AMQCP] for 7 days. Both treatment regimens were well tolerated and no patient was withdrawn as a result of recurrent vomiting or drug-related adverse events. There was no significant difference in mean fever and parasite clearance times. The cure rates at day 7 were 90.2 versus 100% [= 0.027] for AMQ versus AMQCP, while the day 14 cure rates were 85.9 versus 98.1% for AMQ versus AMQCP, respectively [= 0.016]. The combination of AMQ plus CP proved significantly more effective than AMQ alone in the treatment of acute uncomplicated falciparum malaria, most probably due to the enhancement of the antimalarial effect of AMQ by CP. The combination of AMQCP could be a better alternative to AMQ alone as a companion drug in artemisinin-based combination therapies