{"doi":"10.1186/s12936-015-0682-7","title":"Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem®)","abstract":null,"journal":"Malaria Journal","year":2015,"id":648075,"datarank":0.7484213621710015,"base_score":2.70805020110221,"endowment":2.70805020110221,"self_citation_contribution":0.40620753016533157,"citation_network_contribution":0.34221383200566996,"self_endowment_contribution":0.40620753016533157,"citer_contribution":0.34221383200566996,"corpus_percentile":null,"corpus_rank":null,"citation_count":14,"citer_count":10,"citers_with_citation_signal":7,"citers_with_endowment":7,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":null,"is_data_producer":false,"deposit_databanks":null,"is_oa":false,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":null,"fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":1269664,"name":"Halidou Tinto","orcid":"0000-0003-4653-7041","position":1,"is_corresponding":false},{"id":1688764,"name":"Maroufou J Alao","orcid":null,"position":2,"is_corresponding":false},{"id":1055351,"name":"Martin Meremikwu","orcid":"0000-0002-6144-9413","position":3,"is_corresponding":false},{"id":270631,"name":"Antoinette Tshefu","orcid":"0000-0001-7657-6901","position":4,"is_corresponding":false},{"id":942024,"name":"Bernhards Ogutu","orcid":"0000-0002-0992-5654","position":5,"is_corresponding":false},{"id":1688770,"name":"Alphonse Ouedraogo","orcid":null,"position":6,"is_corresponding":false},{"id":1269661,"name":"Moussa Lingani","orcid":"0000-0002-5651-2035","position":7,"is_corresponding":false},{"id":1688773,"name":"Marc Cousin","orcid":null,"position":8,"is_corresponding":false},{"id":1688774,"name":"Gilbert Lefèvre","orcid":null,"position":9,"is_corresponding":false},{"id":50468,"name":"Jay Prakash Jain","orcid":null,"position":10,"is_corresponding":false},{"id":1592581,"name":"Stephan Duparc","orcid":null,"position":11,"is_corresponding":false},{"id":1688775,"name":"Kamal Hamed","orcid":"0000-0003-1896-9736","position":12,"is_corresponding":false},{"id":1688761,"name":"Alfred B Tiono","orcid":null,"position":0,"is_corresponding":false}],"reference_count":0,"raw_metadata":{"has_enrichment":true,"resolved":true,"title":"Increased systemic exposures of artemether and dihydroartemisinin in infants under 5 kg with uncomplicated Plasmodium falciparum malaria treated with artemether-lumefantrine (Coartem®)","abstract":"BACKGROUND: Artemether-lumefantrine (AL) dispersible formulation was developed for the treatment of uncomplicated Plasmodium falciparum malaria in infants and children weighing 5 to <35 kg. However, there are no clinical studies with artemisinin-based combination therapy in infants <5 kg. METHODS: This multicentre, open-label, single-arm study evaluated the efficacy, safety and pharmacokinetics of AL dispersible in infants aged >28 days and <5 kg of body weight, who were treated with one AL dispersible tablet (20 mg artemether/120 mg lumefantrine) given twice-daily for three days and followed up for six weeks (core follow-up) and at 12 months of age (long-term follow-up). RESULTS: A total of 20 patients were enrolled and completed the six-week core study follow-up. In the per protocol population, PCR-corrected cure rate at days 28 and 42 was 100% (95% CI: 79.4, 100). AL dispersible was well tolerated with reported adverse events of mild to moderate severity. Pharmacokinetic data showed that lumefantrine levels were similar, however, artemether and dihydroartemisinin levels were on average two- to three-fold greater than historical values in infants and children ≥5 kg. CONCLUSIONS: A three-day regimen of AL dispersible formulation was efficacious and generally well tolerated in infants weighing <5 kg with uncomplicated P. falciparum malaria, but artemether and dihydroartemisinin exposures could not be supported by the preclinical safety margins for neurotoxicity. Hence, dosing recommendations cannot be made in infants <5 kg as implications for toxicity are unknown. TRIAL REGISTRATION: Clinicaltrials.gov NCT01619878.","is_dataset_classified":null,"base_score":2.70805020110221,"endowment":2.70805020110221,"datacite_reuse_total":0,"file_count":0,"downloads":0,"views":0,"has_version_chain":false,"is_dataset":false,"is_oa":false,"pmid":"25886021","pmcid":null,"openalex_id":"https://openalex.org/W2042138153","authors":[],"funders":[],"total_grants":0,"fwci":0.9857,"citation_percentile":0.79637683,"influential_citations":0,"citation_trend":[{"year":2016,"count":1},{"year":2018,"count":2},{"year":2019,"count":1},{"year":2020,"count":2},{"year":2021,"count":1},{"year":2022,"count":1},{"year":2024,"count":2},{"year":2025,"count":2},{"year":2026,"count":2}],"oa_status":"gold","license":"cc-by","oa_locations":[{"url":"https://malariajournal.biomedcentral.com/counter/pdf/10.1186/s12936-015-0682-7","host_type":"journal"},{"url":"https://malariajournal.biomedcentral.com/counter/pdf/10.1186/s12936-015-0682-7","host_type":"publisher"},{"url":"http://link.springer.com/content/pdf/10.1186/s12936-015-0682-7.pdf","host_type":"publisher"},{"url":"http://link.springer.com/article/10.1186/s12936-015-0682-7/fulltext.html","host_type":"publisher"},{"url":"http://link.springer.com/content/pdf/10.1186/s12936-015-0682-7","host_type":"publisher"},{"url":"https://link.springer.com/content/pdf/10.1186/s12936-015-0682-7.pdf","host_type":"publisher"},{"url":"https://doi.org/10.1186/s12936-015-0682-7","host_type":"journal"},{"url":"https://pubmed.ncbi.nlm.nih.gov/25886021","host_type":"repository"},{"url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4407414","host_type":"repository"}],"fields_of_study":["Malaria Research and Control","Pharmaceutical Quality and Counterfeiting","Historical Medical Research and Treatments"],"mesh_terms":["Artemether, Lumefantrine Drug Combination","Antimalarials","Drug Combinations","Ethanolamines","Female","Fluorenes","Humans","Infant","Male","Malaria, Falciparum","Treatment Outcome","Artemisinins","Drug-Related Side Effects and Adverse Reactions"],"keywords":["Artemether/lumefantrine","Artemether","Lumefantrine","Medicine","Dihydroartemisinin","Regimen","Malaria","Artemisinin","Pharmacokinetics","Dosing","Adverse effect","Plasmodium falciparum","Population","Pharmacology","Internal medicine","Immunology"],"sdg_mappings":[{"sdg_number":0,"sdg_label":"Good health and well-being"}],"linked_datasets":[],"clinical_trials":[],"software_tools":[],"database_accessions":[],"source":"live","citation_network_status":"fetched"},"created_at":"2026-08-10T02:12:43.327434Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}