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).

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Title: 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).
Authors: Wounounou G; Saint Luc Hospital, Kisantu, Central Kongo, Democratic Republic of the Congo., Tiono AB; Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso., Ogutu B; Kenya Medical Research Institute, Nairobi, Kenya.; CREATES, Strathmore University, Nairobi, Kenya., Manyando C; National Health Research and Training Institute (Formerly TDRC), Ndola, Zambia., Sagara I; University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali., Schneitter S; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland., Bassat Q; ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.; Centro de Investigação Em Saúde de Manhiça (CISM), Maputo, Mozambique.; ICREA, Pg. Lluís Companys 23, 08010, Barcelona, Spain.; Institut Clínic de Medicina I Dermatologia' Hospital Clínic de Barcelona, Barcelona, Spain.; Facultat de Medicina I Ciències de La Salut, Universitat de Barcelona (UB), Barcelona, Spain.; CIBER de Epidemiología y Salud Pública, Instituto de Salud Carlos III, Madrid, Spain., Gaaloul ME; Medicines for Malaria Venture, Meyrin, Switzerland., Marrast AC; Medicines for Malaria Venture, Meyrin, Switzerland., Demin I; Novartis Pharma AG, Basel, Switzerland., Winnips C; Novartis Pharma AG, Basel, Switzerland., Risterucci C; Novartis Pharma AG, Basel, Switzerland., Hugot S; Novartis Pharma AG, Basel, Switzerland., Hofstetter G; Novartis Pharma AG, Basel, Switzerland., Qian Z; Novartis Pharma AG, Basel, Switzerland., Su G; Novartis Pharmaceutical Corporation, East Hanover, NJ, USA., Zhang J; Novartis Pharmaceutical Corporation, East Hanover, NJ, USA., Renner KC; Novartis Pharma AG, Basel, Switzerland., Cousin M; Novartis Pharma AG, Basel, Switzerland., Venishetty VK; Novartis Healthcare Private Limited, Hyderabad, India., Sayyed S; Novartis Healthcare Private Limited, Hyderabad, India., Gandhi P; Novartis Pharma AG, Basel, Switzerland. preetam.gandhi@novartis.com., Kabore B; Institut de Recherche en Sciences de La Sante, Clinical Research Unit of Nanoro (IRSS-CRUN), Ouagadougou, Burkina Faso.
Corporate Authors: CALINA study group
Source: Tropical medicine and health [Trop Med Health] 2025 Nov 06; Vol. 53 (1), pp. 151. Date of Electronic Publication: 2025 Nov 06.
Publication Type: Journal Article
Journal Info: Publisher: BioMed Central Ltd Country of Publication: Japan NLM ID: 101215093 Publication Model: Electronic Cited Medium: Print ISSN: 1348-8945 (Print) Linking ISSN: 13488945 NLM ISO Abbreviation: Trop Med Health Subsets: PubMed not MEDLINE
Database: MEDLINE Ultimate
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Description
ISSN:1348-8945
DOI:10.1186/s41182-025-00828-z