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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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  Data: 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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  Data: <searchLink fieldCode="AU" term="%22Wounounou+G%22">Wounounou G</searchLink>; Saint Luc Hospital, Kisantu, Central Kongo, Democratic Republic of the Congo.<br /><searchLink fieldCode="AU" term="%22Tiono+AB%22">Tiono AB</searchLink>; Groupe de Recherche Action en Santé (GRAS), Ouagadougou, Burkina Faso.<br /><searchLink fieldCode="AU" term="%22Ogutu+B%22">Ogutu B</searchLink>; Kenya Medical Research Institute, Nairobi, Kenya.; CREATES, Strathmore University, Nairobi, Kenya.<br /><searchLink fieldCode="AU" term="%22Manyando+C%22">Manyando C</searchLink>; National Health Research and Training Institute (Formerly TDRC), Ndola, Zambia.<br /><searchLink fieldCode="AU" term="%22Sagara+I%22">Sagara I</searchLink>; University of Sciences, Techniques and Technologies of Bamako, Bamako, Mali.<br /><searchLink fieldCode="AU" term="%22Schneitter+S%22">Schneitter S</searchLink>; Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; University of Basel, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Bassat+Q%22">Bassat Q</searchLink>; 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.<br /><searchLink fieldCode="AU" term="%22Gaaloul+ME%22">Gaaloul ME</searchLink>; Medicines for Malaria Venture, Meyrin, Switzerland.<br /><searchLink fieldCode="AU" term="%22Marrast+AC%22">Marrast AC</searchLink>; Medicines for Malaria Venture, Meyrin, Switzerland.<br /><searchLink fieldCode="AU" term="%22Demin+I%22">Demin I</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Winnips+C%22">Winnips C</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Risterucci+C%22">Risterucci C</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Hugot+S%22">Hugot S</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Hofstetter+G%22">Hofstetter G</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Qian+Z%22">Qian Z</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Su+G%22">Su G</searchLink>; Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Zhang+J%22">Zhang J</searchLink>; Novartis Pharmaceutical Corporation, East Hanover, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Renner+KC%22">Renner KC</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Cousin+M%22">Cousin M</searchLink>; Novartis Pharma AG, Basel, Switzerland.<br /><searchLink fieldCode="AU" term="%22Venishetty+VK%22">Venishetty VK</searchLink>; Novartis Healthcare Private Limited, Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Sayyed+S%22">Sayyed S</searchLink>; Novartis Healthcare Private Limited, Hyderabad, India.<br /><searchLink fieldCode="AU" term="%22Gandhi+P%22">Gandhi P</searchLink>; Novartis Pharma AG, Basel, Switzerland. preetam.gandhi@novartis.com.<br /><searchLink fieldCode="AU" term="%22Kabore+B%22">Kabore B</searchLink>; Institut de Recherche en Sciences de La Sante, Clinical Research Unit of Nanoro (IRSS-CRUN), Ouagadougou, Burkina Faso.
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