ArticleTropical medicine and health2025
Pharmacokinetics, safety and efficacy of an optimized dose of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in neonates and infants of less than 5 kg body weight: a multicentre, open-label, single-arm phase 2/3 study (CALINA).
Article in Tropical medicine and health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04300309 (Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether), which is not on this map. Cited by 2 papers.
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.
Multicenter, Open-label, Single-arm Study to Evaluate the PK, Safety, Tolerability and Efficacy of a New Artemether:Lumefantrine (2.5 mg:30 mg) Dispersible Tablet in the Treatment of Infants and Neonates <5 kg Body Weight With Acute Uncomplicated Plasmodium Falciparum Malaria
Who cites it
2 citing papers in PubMed.
- Malaria in children aged <6 months: a narrative review of current evidence, recommendations and practice gaps.Tropical medicine and health · 2026Review
- Physiologically based pharmacokinetic modelling to predict artemether and lumefantrine exposure in neonates weighing less than 5 kg treated with artemether-lumefantrine to supplement the clinical data from the CALINA study.Tropical medicine and health · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
24 authors.
Funding
Abstract
backgroundTreatment recommendations for malaria in infants of < 5 kg body weight (BW) are not evidence-based. Due to pharmacokinetic characteristics of this population, weight-based dose adjustments for antimalarials may be suboptimal. The 20 mg artemether:120 mg lumefantrine dispersible tablet, even with dose adjustment, may lead to artemether over-exposure and reduced lumefantrine exposure in patients < 5 kg. PBPK modelling predicted that a 1:12 artemether:lumefantrine ratio dispersible tablet should match efficacious and safe drug exposures in patients 5- < 15 kg treated with the current artemether-lumefantrine dispersible tablet: the CALINA study used an exposure-matching approach to confirm that drug exposures were comparable.
methodsSequential age cohorts (Cohort 1: > 28 days; Cohort 2: 1-28 days) of patients < 5 kg with Plasmodium falciparum malaria received the new artemether-lumefantrine dispersible tablet (each dose 5 mg artemether: 60 mg lumefantrine) twice daily for 3 days. Artemether C
resultsIn Cohort 1 (N = 22), geometric mean artemether C
conclusionsThe optimized dose of artemether-lumefantrine (5 mg/60 mg) achieves the exposures required for optimal efficacy and safety in patients < 5 kg body weight with P. falciparum malaria, consistent with those in patients 5- < 15 kg treated with the current dispersible tablet (20 mg/120 mg). TRIAL REGISTRY: Clinicaltrials.gov: NCT04300309.
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