Trial reportAntimicrobial agents and chemotherapy2004
Disposition of artesunate and dihydroartemisinin after administration of artesunate suppositories in children from Papua New Guinea with uncomplicated malaria.
Trial report in Antimicrobial agents and chemotherapy, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Artemisinin Therapy for Malaria in Hemoglobinopathies: A Systematic Review.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018Pooled it
- Pre-referral rectal artesunate for severe malaria.The Cochrane database of systematic reviews · 2014Pooled it
- Pooled it
- Opposite malaria and pregnancy effect on oral bioavailability of artesunate - a population pharmacokinetic evaluation.British journal of clinical pharmacology · 2015Trial
- Pharmacokinetics of a novel sublingual spray formulation of the antimalarial drug artemether in African children with malaria.Antimicrobial agents and chemotherapy · 2015Trial
- Intermittent preventive treatment for malaria in Papua New Guinean infants exposed to Plasmodium falciparum and P. vivax: a randomized controlled trial.PLoS medicine · 2012Trial
- Artesunate suppositories versus intramuscular artemether for treatment of severe malaria in children in Papua New Guinea.Antimicrobial agents and chemotherapy · 2006Trial
- Frequencies of CYP2B6Genetics research · 2021Article
- Population pharmacokinetics of intravenous artesunate: a pooled analysis of individual data from patients with severe malaria.CPT: pharmacometrics & systems pharmacology · 2014Article
- Population pharmacokinetics of intramuscular artesunate in African children with severe malaria: implications for a practical dosing regimen.Clinical pharmacology and therapeutics · 2013Article
- Review of the clinical pharmacokinetics of artesunate and its active metabolite dihydroartemisinin following intravenous, intramuscular, oral or rectal administration.Malaria journal · 2011Review
- Population pharmacokinetics of artesunate and dihydroartemisinin following single- and multiple-dosing of oral artesunate in healthy subjects.Malaria journal · 2009Article
- Towards optimal design of anti-malarial pharmacokinetic studies.Malaria journal · 2009Article
- Rectal artemisinins for malaria: a review of efficacy and safety from individual patient data in clinical studies.BMC infectious diseases · 2008Review
- Clinical pharmacology of artemisinin-based combination therapies.Clinical pharmacokinetics · 2008Review
- Prevalence of UGT1A9 and UGT2B7 nonsynonymous single nucleotide polymorphisms in West African, Papua New Guinean, and North American populations.European journal of clinical pharmacology · 2007Article
- Population pharmacokinetics of artesunate and dihydroartemisinin following intra-rectal dosing of artesunate in malaria patients.PLoS medicine · 2006Article
- Prevalence of CYP2B6 alleles in malaria-endemic populations of West Africa and Papua New Guinea.European journal of clinical pharmacology · 2006Article
- Artemisinins.Postgraduate medical journal · 2005Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 4 institutions in 4 countries.
Funding
Abstract
A detailed pharmacokinetic analysis was performed with 47 children from Papua New Guinea with uncomplicated falciparum or vivax malaria treated with artesunate (ARTS) suppositories (Rectocaps) given in two doses of approximately 13 mg/kg of body weight 12 h apart. Following an intensive sampling protocol, samples were assayed for ARTS and its primary active metabolite, dihydroartemisinin (DHA), by liquid chromatography-mass spectrometry. A population pharmacokinetic model was developed to describe the data. Following administration of the first dose, the mean maximal concentrations of ARTS and DHA were 1,085 nmol/liter at 0.9 h and 2,525 nmol/liter at 2.3 h, respectively. The absorption half-life for ARTS was 2.3 h, and the conversion half-life (ARTS to DHA) was 0.27 h, while the elimination half-life of DHA was 0.71 h. The mean common volumes of distribution for ARTS and DHA relative to bioavailability were 42.8 and 2.04 liters/kg, respectively, and the mean clearance values relative to bioavailability were 6 and 2.2 liters/h/kg for ARTS and DHA, respectively. Substantial interpatient variability was observed, and the bioavailability of the second dose relative to that of the first was estimated to be 0.72. The covariates age, sex, and alpha-thalassemia genotype were not influential in the pharmacokinetic model development; but the inclusion of weight as a covariate significantly improved the performance of the model. An ARTS suppositories dose of 10 of 20 mg/kg is appropriate for use in children with uncomplicated malaria.
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