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Randomized Controlled Trial
. 2006 Nov 14:5:108.
doi: 10.1186/1475-2875-5-108.

Combined chloroquine, sulfadoxine/pyrimethamine and primaquine against Plasmodium falciparum in Central Java, Indonesia

Edith R Lederman  1 , Jason D Maguire, Iwa W Sumawinata, Krisin Chand, Iqbal Elyazar, Lusi Estiana, Priyanto Sismadi, Michael J Bangs, J Kevin Baird
Affiliations
Randomized Controlled Trial

Combined chloroquine, sulfadoxine/pyrimethamine and primaquine against Plasmodium falciparum in Central Java, Indonesia

Edith R Lederman et al. Malar J. .

Abstract

Background: Chloroquine (CQ) or sulfadoxine-pyrimethamine (SP) monotherapy for Plasmodium falciparum often leads to therapeutic failure in Indonesia. Combining CQ with other drugs, like SP, may provide an affordable, available and effective option where artemisinin-combined therapies (ACT) are not licensed or are unavailable.

Methods: This study compared CQ (n = 29 subjects) versus CQ + SP (with or without primaquine; n = 88) for clinical and parasitological cure of uncomplicated falciparum malaria in the Menoreh Hills region of southern Central Java, Indonesia. Gametocyte clearance rates were measured with (n = 56 subjects) and without (n = 61) a single 45 mg dose of primaquine (PQ).

Results: After 28 days, 58% of subjects receiving CQ had cleared parasitaemia and remained aparasitaemic, compared to 94% receiving CQ combined with SP (p < 0.001). Msp-2 genotyping permitted reinfection-adjusted cure rates for CQ and CQ combined with SP, 70% and 99%, respectively (p = 0.0006).

Conclusion: Primaquine exerted no apparent affect on cure of asexual stage parasitaemia, but clearly accelerated clearance of gametocytes. CQ combined with SP was safe and well-tolerated with superior efficacy over CQ for P. falciparum parasitaemia in this study.

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Figures

Figure 1
Figure 1
The recruitment, enrollment and randomization process for this study evaluating four treatment regimens for uncomplicated P. falciparum in residents of Purworejo District, Central Java, Indonesia.
Figure 2
Figure 2
(A) Asexual parasite clearance time in 117 subjects with falciparum malaria after treatment with one of 4 different regimens. (B) Time of fever clearance in 38 subjects with fever at the time of study enrollment. CQ = chloroquine, SP = sulfadoxine/pyrimethamine, and PQ = primaquine on either day 0 (d0) or day 2(d2) of therapy.
Figure 3
Figure 3
Gametocyte rates in 117 subjects with falciparum malaria after treatment with one of 4 different regimens. CQ = chloroquine, SP = sulfadoxine/pyrimethamine, and PQ = primaquine on either day 0 (d0) or day 2(d2) of therapy.
See this image and copyright information in PMC

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