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Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren.

Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG - PLoS ONE (2010)

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Uganda Malaria Surveillance Project, Kampala, Uganda.

ABSTRACT

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.

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Related in: MedlinePlus

Trial profile.SP  =  sulfadoxine-pyrimethamine; AQ+SP  =  amodiaquine + sulfadoxine-pyrimethamine; DP  =  dihydroartemisinin-piperaquine; PD  =  parasite density.
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pone-0013438-g001: Trial profile.SP  =  sulfadoxine-pyrimethamine; AQ+SP  =  amodiaquine + sulfadoxine-pyrimethamine; DP  =  dihydroartemisinin-piperaquine; PD  =  parasite density.

Mentions: Of 894 children initially screened, 794 (88.8%) met the inclusion criteria and were randomized to one of the treatment arms (Figure 1). Fourteen children had a parasite density of >10,000/µl and were excluded after randomization. Of the 780 children enrolled, 769 (98.6%) completed follow-up and were included in the primary outcome analysis. The characteristics of participants randomized to each treatment were similar, although children receiving AQ+SP were less likely to be parasitemic (Table 1). Just over half (399 [51.3%]) of children were parasitemic at enrollment. Nearly all infections were P. falciparum.


Efficacy, safety, and tolerability of three regimens for prevention of malaria: a randomized, placebo-controlled trial in Ugandan schoolchildren.

Nankabirwa J, Cundill B, Clarke S, Kabatereine N, Rosenthal PJ, Dorsey G, Brooker S, Staedke SG - PLoS ONE (2010)

Trial profile.SP  =  sulfadoxine-pyrimethamine; AQ+SP  =  amodiaquine + sulfadoxine-pyrimethamine; DP  =  dihydroartemisinin-piperaquine; PD  =  parasite density.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2957410&req=5

pone-0013438-g001: Trial profile.SP  =  sulfadoxine-pyrimethamine; AQ+SP  =  amodiaquine + sulfadoxine-pyrimethamine; DP  =  dihydroartemisinin-piperaquine; PD  =  parasite density.
Mentions: Of 894 children initially screened, 794 (88.8%) met the inclusion criteria and were randomized to one of the treatment arms (Figure 1). Fourteen children had a parasite density of >10,000/µl and were excluded after randomization. Of the 780 children enrolled, 769 (98.6%) completed follow-up and were included in the primary outcome analysis. The characteristics of participants randomized to each treatment were similar, although children receiving AQ+SP were less likely to be parasitemic (Table 1). Just over half (399 [51.3%]) of children were parasitemic at enrollment. Nearly all infections were P. falciparum.

Bottom Line: 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).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.

View Article: PubMed Central - PubMed

Affiliation: Uganda Malaria Surveillance Project, Kampala, Uganda.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus