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Comparative Evaluation of the Efficacy of Chloroquine and Sulphadoxine-Pyrimethamine in the Treatment of Uncomplicated Malaria in Children Under Five Years in a Rural Population of Enugu State
Abstract
Objective: To determine and compare the in vivo efficacy of the trial drugs chloroquine and sulphadoxine-pyrimethamine in the treatment of uncomplicated malaria in under 5 children.
Study Design and Methods: This was a comparative clinical trial conducted at Ugwuogo Nike, a rural community, in South east Nigeria. Patients were selected by convenience method and allotted to trial drugs by randomization. Fifty-five patients were allocated to each treatment group (chloroquine and sulphadoxine-pyrimethamine). Patients were enrolled after informed consents were obtained. Historical, physical and laboratory data were obtained to determine the baseline characteristics: age, sex, place of domicile, clinical status of the children. The haematocrit and parasite density were also determined for each patient and repeated on Days 1, 2, 3, 7, 14. Drugs were administered by direct observation methods. Data obtained were analysed with parametric and nonparametric tests to determine significance and associations.
Results: The study was conducted from July 29th to September 8th 2002, and one hundred and ten (110) children aged 6 to 59 months with malaria were recruited. The baseline characteristics of the enrolled patients in the two treatment groups were similar except for the mean weights. Fever clearance time for both drugs; chloroquine and sulphadoxine- pyrimethamine, respectively was 32.29 hours (± 17.42). There were 26 cases of early treatment failure in the chloroquine group and 17 in the S-P group (p > 0.05). The proportions of late parasitological failure was 43.6% for each of the treatment groups. Only two and seven cases in the respective groups had adequate clinical and parasitological response (p > 0.05), however clinical efficacy was 56.3% for SP and 47.2% for chloroquine.
Conclusion: The number of early treatment failures in both treatment groups exceeds the acceptable limit of 25%. It is therefore recommended that combination therapy regimens with cheaper and easily available drugs should be adopted rather than monotherapy.
Key Words: Chloroquine, Sulfadoxine/ Pyrimethamine, Efficacy, Children
Journal of College of Medicine 2005: 9(2): 77-81
Study Design and Methods: This was a comparative clinical trial conducted at Ugwuogo Nike, a rural community, in South east Nigeria. Patients were selected by convenience method and allotted to trial drugs by randomization. Fifty-five patients were allocated to each treatment group (chloroquine and sulphadoxine-pyrimethamine). Patients were enrolled after informed consents were obtained. Historical, physical and laboratory data were obtained to determine the baseline characteristics: age, sex, place of domicile, clinical status of the children. The haematocrit and parasite density were also determined for each patient and repeated on Days 1, 2, 3, 7, 14. Drugs were administered by direct observation methods. Data obtained were analysed with parametric and nonparametric tests to determine significance and associations.
Results: The study was conducted from July 29th to September 8th 2002, and one hundred and ten (110) children aged 6 to 59 months with malaria were recruited. The baseline characteristics of the enrolled patients in the two treatment groups were similar except for the mean weights. Fever clearance time for both drugs; chloroquine and sulphadoxine- pyrimethamine, respectively was 32.29 hours (± 17.42). There were 26 cases of early treatment failure in the chloroquine group and 17 in the S-P group (p > 0.05). The proportions of late parasitological failure was 43.6% for each of the treatment groups. Only two and seven cases in the respective groups had adequate clinical and parasitological response (p > 0.05), however clinical efficacy was 56.3% for SP and 47.2% for chloroquine.
Conclusion: The number of early treatment failures in both treatment groups exceeds the acceptable limit of 25%. It is therefore recommended that combination therapy regimens with cheaper and easily available drugs should be adopted rather than monotherapy.
Key Words: Chloroquine, Sulfadoxine/ Pyrimethamine, Efficacy, Children
Journal of College of Medicine 2005: 9(2): 77-81
