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, Salah Eldin El-Zaki, Hamza Babiker, Nahla Gadalla, Tellal Ageep, Fathi Mansour, Omer Baraka, Paul Milligan, Ahmed Babiker

Research output: Contribution to journalArticle

34 Citations (Scopus)

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 210.3% 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 29.3% 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.

Original languageEnglish
Article numbere1311
JournalPLoS One
Volume2
Issue number12
DOIs
Publication statusPublished - Dec 12 2007

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sulfadoxine
Primaquine
pyrimethamine
gametocytes
Sudan
Parasitemia
parasitemia
Labels
dry season
malaria
Malaria
Malaria control
Polymerase Chain Reaction
Pharmaceutical Preparations
artemisinin
drugs
Screening
risk groups
sulfadoxine-pyrimethamine-artesunate
villages

ASJC Scopus subject areas

  • Agricultural and Biological Sciences(all)
  • Biochemistry, Genetics and Molecular Biology(all)
  • Medicine(all)

Cite this

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. / El-Sayed, Badria; El-Zaki, Salah Eldin; Babiker, Hamza; Gadalla, Nahla; Ageep, Tellal; Mansour, Fathi; Baraka, Omer; Milligan, Paul; Babiker, Ahmed.

In: PLoS One, Vol. 2, No. 12, e1311, 12.12.2007.

Research output: Contribution to journalArticle

El-Sayed, Badria ; El-Zaki, Salah Eldin ; Babiker, Hamza ; Gadalla, Nahla ; Ageep, Tellal ; Mansour, Fathi ; Baraka, Omer ; Milligan, Paul ; Babiker, Ahmed. / 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. In: PLoS One. 2007 ; Vol. 2, No. 12.
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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 210.3{\%} 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 29.3{\%} 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.",
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