Efficacy, Safety, and Tolerability of Three Regimens for Prevention of Malaria: A Randomized, Placebo-Controlled Trial in Ugandan SchoolchildrenReport as inadecuate




Efficacy, Safety, and Tolerability of Three Regimens for Prevention of Malaria: A Randomized, Placebo-Controlled Trial in Ugandan Schoolchildren - Download this document for free, or read online. Document in PDF available to download.

Background

Intermittent preventive treatment IPT is a promising malaria control strategy; however, the optimal regimen remains unclear. We conducted a randomized, single-blinded, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of a single course of sulfadoxine-pyrimethamine SP, amodiaquine + SP AQ+SP or dihydroartemisinin-piperaquine DP among schoolchildren to inform IPT.

Methods

Asymptomatic girls aged 8 to 12 years and boys aged 8 to 14 years enrolled in two primary schools in Tororo, Uganda were randomized to receive one of the study regimens or placebo, regardless of presence of parasitemia at enrollment, and followed for 42 days. The primary outcome was risk of parasitemia at 42 days. Survival analysis was used to assess differences between regimens.

Results

Of 780 enrolled participants, 769 98.6% completed follow-up and were assigned a treatment outcome. The risk of parasitemia at 42 days varied significantly between DP 11.7% 95% confidence interval CI: 7.9, 17.1, AQ+SP 44.3% 37.6, 51.5, and SP 79.7% 95% CI: 73.6, 85.2, p<0.001. The risk of parasitemia in SP-treated children was no different than in those receiving placebo 84.6% 95% CI: 79.1, 89.3, p = 0.22. No serious adverse events occurred, but AQ+SP was associated with increased risk of vomiting compared to placebo 13.0% 95% CI: 9.1, 18.5 vs. 4.7% 95% CI: 2.5, 8.8, respectively, p = 0.003.

Conclusions

DP was the most efficacious and well-tolerated regimen tested, although AQ+SP appears to be a suitable alternative for IPT in schoolchildren. Use of SP for IPT may not be appropriate in areas with high-level SP resistance in Africa.

Trial Registration

ClinicalTrials.gov NCT00852371



Author: Joaniter Nankabirwa, Bonnie Cundill, Sian Clarke, Narcis Kabatereine, Philip J. Rosenthal, Grant Dorsey, Simon Brooker, Sarah G.

Source: http://plos.srce.hr/



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