Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2007 Dec 12;2(12):e1311.
doi: 10.1371/journal.pone.0001311.

A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan

Badria El-Sayed  1 , Salah-Eldin El-Zaki, Hamza Babiker, Nahla Gadalla, Tellal Ageep, Fathi Mansour, Omer Baraka, Paul Milligan, Ahmed Babiker
Affiliations
Randomized Controlled Trial

A randomized open-label trial of artesunate- sulfadoxine-pyrimethamine with or without primaquine for elimination of sub-microscopic P. falciparum parasitaemia and gametocyte carriage in eastern Sudan

Badria El-Sayed et al. PLoS One. .

Abstract

Background: In areas of seasonal malaria transmission, treatment of asymptomatic carriers of malaria parasites, whose parasitaemia persists at low densities throughout the dry season, could be a useful strategy for malaria control. We carried out a randomized trial to compare two drug regimens for clearance of parasitaemia in order to identify the optimum regimen for use in mass drug administration in the dry season.

Methodology and principal findings: A two-arm open-label randomized controlled trial was conducted during the dry season in an area of distinct seasonal malaria in two villages in Gedarif State in eastern Sudan. Participants were asymptomatic adults and children aged over 6 months, with low-density P. falciparum infection detected by PCR. Participants were randomized to receive artesunate/sulfadoxine-pyrimethamine (AS+SP) combination for three days with or without a dose of primaquine (PQ) on the fourth day. Parasitaemia detected by PCR on days 3, 7 and 14 after the start of treatment and gametocytes detected by RT-PCR on days 7 and 14 were then recorded. 104 individuals who had low density parasitaemia at screening were randomized and treated during the dry season. On day 7, 8.3% were positive by PCR in the AS+SP+PQ group and 6.5% in the AS+SP group (risk difference 1.8%, 95%CI -10.3% to +13.8%). At enrolment, 12% (12/100) were carrying gametocytes. This was reduced to 6.4% and 4.4% by day 14 (Risk difference 1.9% (95%CI -9.3% to +13.2%) in AS+SP+PQ and AS+SP groups, respectively.

Conclusion: Addition of primaquine to artemisinin combination treatment did not improve elimination of parasitaemia and prevention of gametocyte carriage in carriers with low-density parasitaemia in the dry season.

Trial registration: ClinicalTrials.gov NCT00330902.

PubMed Disclaimer

Conflict of interest statement

Competing Interests: The authors have declared that no competing interests exist.

Figures

Figure 1
Figure 1. CONSORT Flowchart
See this image and copyright information in PMC

References

    1. Roper C, Elhassan IM, Hviid L, Giha H, Richardson W, et al. Detection of Very Low Level Plasmodium falciparum Infections using the Nested Polymerase Chain Reaction and a Reassessment of the Epidemiology of Unstable Malaria in Sudan. Am J Trop Med Hyg. 1996;54:325–331. - PubMed
    1. Babiker HA, Abdel-Muhsin AM, Ranford-Cartwright LC, Satti G, Walliker D. Characteristics of Plasmodium falciparum parasites that survive the lengthy dry season in eastern Sudan where malaria transmission is markedly seasonal. Am J Trop Med Hyg. 1998;59:582–590. - PubMed
    1. Babiker HA, Abdel-Muhsin AA, Hamad A, Mackinnon MJ, Hill WG, et al. Population dynamics of Plasmodium falciparum in an unstable malaria area of eastern Sudan. Parasitology. 2000;120(Pt 2):105–111. - PubMed
    1. Babiker HA, Abdel-Wahab A, Ahmed S, Suleiman S, Ranford-Cartwright L, et al. Detection of low level Plasmodium falciparum gametocytes using reverse transcriptase polymerase chain reaction. Mol Biochem Parasitol. 1999;99:143–148. - PubMed
    1. Menegon M, Severini C, Sannella A, Paglia MG, Sangare D, et al. Genotyping of Plasmodium falciparum gametocytes by reverse transcriptase polymerase chain reaction. Mol Biochem Parasitol. 2000;111:153–161. - PubMed

Publication types

MeSH terms

Associated data