Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges

<p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis wer...
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Autor*in:	Bassat Quique [verfasserIn] González Raquel [verfasserIn] Machevo Sónia [verfasserIn] Nahum Alain [verfasserIn] Lyimo John [verfasserIn] Maiga Hamma [verfasserIn] Mårtensson Andreas [verfasserIn] Bashraheil Mahfudh [verfasserIn] Ouma Peter [verfasserIn] Ubben David [verfasserIn] Walter Verena [verfasserIn] Nwaiwu Obiyo [verfasserIn] Kipkeu Chemtai [verfasserIn] Lefèvre Gilbert [verfasserIn] Ogutu Bernhards [verfasserIn] Menéndez Clara [verfasserIn]

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2011

Übergeordnetes Werk:	In: Malaria Journal - BMC, 2003, 10(2011), 1, p 369
Übergeordnetes Werk:	volume:10 ; year:2011 ; number:1, p 369

Links:	Link aufrufen Link aufrufen Link aufrufen Journal toc

DOI / URN:	10.1186/1475-2875-10-369

Katalog-ID:	DOAJ034509275

Internformat


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245	1	0	\|a Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
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520			\|a <p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p<
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allfields	10.1186/1475-2875-10-369 doi (DE-627)DOAJ034509275 (DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b DE-627 ger DE-627 rakwb eng RC955-962 RC109-216 Bassat Quique verfasserin aut Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p< Arctic medicine. Tropical medicine Infectious and parasitic diseases González Raquel verfasserin aut Machevo Sónia verfasserin aut Nahum Alain verfasserin aut Lyimo John verfasserin aut Maiga Hamma verfasserin aut Mårtensson Andreas verfasserin aut Bashraheil Mahfudh verfasserin aut Ouma Peter verfasserin aut Ubben David verfasserin aut Walter Verena verfasserin aut Nwaiwu Obiyo verfasserin aut Kipkeu Chemtai verfasserin aut Lefèvre Gilbert verfasserin aut Ogutu Bernhards verfasserin aut Menéndez Clara verfasserin aut In Malaria Journal BMC, 2003 10(2011), 1, p 369 (DE-627)355986582 (DE-600)2091229-8 14752875 nnns volume:10 year:2011 number:1, p 369 https://doi.org/10.1186/1475-2875-10-369 kostenfrei https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b kostenfrei http://www.malariajournal.com/content/10/1/369 kostenfrei https://doaj.org/toc/1475-2875 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2011 1, p 369
spelling	10.1186/1475-2875-10-369 doi (DE-627)DOAJ034509275 (DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b DE-627 ger DE-627 rakwb eng RC955-962 RC109-216 Bassat Quique verfasserin aut Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p< Arctic medicine. Tropical medicine Infectious and parasitic diseases González Raquel verfasserin aut Machevo Sónia verfasserin aut Nahum Alain verfasserin aut Lyimo John verfasserin aut Maiga Hamma verfasserin aut Mårtensson Andreas verfasserin aut Bashraheil Mahfudh verfasserin aut Ouma Peter verfasserin aut Ubben David verfasserin aut Walter Verena verfasserin aut Nwaiwu Obiyo verfasserin aut Kipkeu Chemtai verfasserin aut Lefèvre Gilbert verfasserin aut Ogutu Bernhards verfasserin aut Menéndez Clara verfasserin aut In Malaria Journal BMC, 2003 10(2011), 1, p 369 (DE-627)355986582 (DE-600)2091229-8 14752875 nnns volume:10 year:2011 number:1, p 369 https://doi.org/10.1186/1475-2875-10-369 kostenfrei https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b kostenfrei http://www.malariajournal.com/content/10/1/369 kostenfrei https://doaj.org/toc/1475-2875 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2011 1, p 369
allfields_unstemmed	10.1186/1475-2875-10-369 doi (DE-627)DOAJ034509275 (DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b DE-627 ger DE-627 rakwb eng RC955-962 RC109-216 Bassat Quique verfasserin aut Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p< Arctic medicine. Tropical medicine Infectious and parasitic diseases González Raquel verfasserin aut Machevo Sónia verfasserin aut Nahum Alain verfasserin aut Lyimo John verfasserin aut Maiga Hamma verfasserin aut Mårtensson Andreas verfasserin aut Bashraheil Mahfudh verfasserin aut Ouma Peter verfasserin aut Ubben David verfasserin aut Walter Verena verfasserin aut Nwaiwu Obiyo verfasserin aut Kipkeu Chemtai verfasserin aut Lefèvre Gilbert verfasserin aut Ogutu Bernhards verfasserin aut Menéndez Clara verfasserin aut In Malaria Journal BMC, 2003 10(2011), 1, p 369 (DE-627)355986582 (DE-600)2091229-8 14752875 nnns volume:10 year:2011 number:1, p 369 https://doi.org/10.1186/1475-2875-10-369 kostenfrei https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b kostenfrei http://www.malariajournal.com/content/10/1/369 kostenfrei https://doaj.org/toc/1475-2875 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2011 1, p 369
allfieldsGer	10.1186/1475-2875-10-369 doi (DE-627)DOAJ034509275 (DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b DE-627 ger DE-627 rakwb eng RC955-962 RC109-216 Bassat Quique verfasserin aut Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p< Arctic medicine. Tropical medicine Infectious and parasitic diseases González Raquel verfasserin aut Machevo Sónia verfasserin aut Nahum Alain verfasserin aut Lyimo John verfasserin aut Maiga Hamma verfasserin aut Mårtensson Andreas verfasserin aut Bashraheil Mahfudh verfasserin aut Ouma Peter verfasserin aut Ubben David verfasserin aut Walter Verena verfasserin aut Nwaiwu Obiyo verfasserin aut Kipkeu Chemtai verfasserin aut Lefèvre Gilbert verfasserin aut Ogutu Bernhards verfasserin aut Menéndez Clara verfasserin aut In Malaria Journal BMC, 2003 10(2011), 1, p 369 (DE-627)355986582 (DE-600)2091229-8 14752875 nnns volume:10 year:2011 number:1, p 369 https://doi.org/10.1186/1475-2875-10-369 kostenfrei https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b kostenfrei http://www.malariajournal.com/content/10/1/369 kostenfrei https://doaj.org/toc/1475-2875 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2011 1, p 369
allfieldsSound	10.1186/1475-2875-10-369 doi (DE-627)DOAJ034509275 (DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b DE-627 ger DE-627 rakwb eng RC955-962 RC109-216 Bassat Quique verfasserin aut Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges 2011 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier <p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p< Arctic medicine. Tropical medicine Infectious and parasitic diseases González Raquel verfasserin aut Machevo Sónia verfasserin aut Nahum Alain verfasserin aut Lyimo John verfasserin aut Maiga Hamma verfasserin aut Mårtensson Andreas verfasserin aut Bashraheil Mahfudh verfasserin aut Ouma Peter verfasserin aut Ubben David verfasserin aut Walter Verena verfasserin aut Nwaiwu Obiyo verfasserin aut Kipkeu Chemtai verfasserin aut Lefèvre Gilbert verfasserin aut Ogutu Bernhards verfasserin aut Menéndez Clara verfasserin aut In Malaria Journal BMC, 2003 10(2011), 1, p 369 (DE-627)355986582 (DE-600)2091229-8 14752875 nnns volume:10 year:2011 number:1, p 369 https://doi.org/10.1186/1475-2875-10-369 kostenfrei https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b kostenfrei http://www.malariajournal.com/content/10/1/369 kostenfrei https://doaj.org/toc/1475-2875 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2031 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2061 GBV_ILN_2111 GBV_ILN_2113 GBV_ILN_2190 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 10 2011 1, p 369
language	English
source	In Malaria Journal 10(2011), 1, p 369 volume:10 year:2011 number:1, p 369
sourceStr	In Malaria Journal 10(2011), 1, p 369 volume:10 year:2011 number:1, p 369
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Arctic medicine. Tropical medicine Infectious and parasitic diseases
isfreeaccess_bool	true
container_title	Malaria Journal
authorswithroles_txt_mv	Bassat Quique @@aut@@ González Raquel @@aut@@ Machevo Sónia @@aut@@ Nahum Alain @@aut@@ Lyimo John @@aut@@ Maiga Hamma @@aut@@ Mårtensson Andreas @@aut@@ Bashraheil Mahfudh @@aut@@ Ouma Peter @@aut@@ Ubben David @@aut@@ Walter Verena @@aut@@ Nwaiwu Obiyo @@aut@@ Kipkeu Chemtai @@aut@@ Lefèvre Gilbert @@aut@@ Ogutu Bernhards @@aut@@ Menéndez Clara @@aut@@
publishDateDaySort_date	2011-01-01T00:00:00Z
hierarchy_top_id	355986582
id	DOAJ034509275
language_de	englisch
fullrecord	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ034509275</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230503061338.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230227s2011 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1186/1475-2875-10-369</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ034509275</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RC955-962</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">RC109-216</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Bassat Quique</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2011</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a"><p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p<</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Arctic medicine. 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callnumber-first	R - Medicine
author	Bassat Quique
spellingShingle	Bassat Quique misc RC955-962 misc RC109-216 misc Arctic medicine. Tropical medicine misc Infectious and parasitic diseases Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
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topic_title	RC955-962 RC109-216 Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
topic	misc RC955-962 misc RC109-216 misc Arctic medicine. Tropical medicine misc Infectious and parasitic diseases
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title	Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
ctrlnum	(DE-627)DOAJ034509275 (DE-599)DOAJc197db8dd11542a39f95f94a3411fb6b
title_full	Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
author_sort	Bassat Quique
journal	Malaria Journal
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author_browse	Bassat Quique González Raquel Machevo Sónia Nahum Alain Lyimo John Maiga Hamma Mårtensson Andreas Bashraheil Mahfudh Ouma Peter Ubben David Walter Verena Nwaiwu Obiyo Kipkeu Chemtai Lefèvre Gilbert Ogutu Bernhards Menéndez Clara
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title_sort	similar efficacy and safety of artemether-lumefantrine (coartem<sup<®</sup<) in african infants and children with uncomplicated falciparum malaria across different body weight ranges
callnumber	RC955-962
title_auth	Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
abstract	<p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p<
abstractGer	<p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p<
abstract_unstemmed	<p<Abstract</p< <p<Background</p< <p<Artemisinin-based combination therapy, including artemether-lumefantrine (AL), is currently recommended for the treatment of uncomplicated <it<Plasmodium falciparum </it<malaria. The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p<
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container_issue	1, p 369
title_short	Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges
url	https://doi.org/10.1186/1475-2875-10-369 https://doaj.org/article/c197db8dd11542a39f95f94a3411fb6b http://www.malariajournal.com/content/10/1/369 https://doaj.org/toc/1475-2875
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author2Str	González Raquel Machevo Sónia Nahum Alain Lyimo John Maiga Hamma Mårtensson Andreas Bashraheil Mahfudh Ouma Peter Ubben David Walter Verena Nwaiwu Obiyo Kipkeu Chemtai Lefèvre Gilbert Ogutu Bernhards Menéndez Clara
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The objectives of the current analysis were to compare the efficacy and safety of AL across different body weight ranges in African children, and to examine the age and body weight relationship in this population.</p< <p<Methods</p< <p<Efficacy, safety and pharmacokinetic data from a randomized, investigator-blinded, multicentre trial of AL for treatment of acute uncomplicated <it<P. falciparum </it<malaria in infants and children in Africa were analysed according to body weight group.</p< <p<Results</p< <p<The trial included 899 patients (intent-to-treat population 886). The modified intent-to-treat (ITT) population (n = 812) comprised 143 children 5 to < 10 kg, 334 children 10 to < 15 kg, 277 children 15 to < 25 kg, and 58 children 25 to < 35 kg. The 28-day PCR cure rate, the primary endpoint, was comparable across all four body weight groups (97.2%, 98.9%, 97.8% and 98.3%, respectively). There were no clinically relevant differences in safety or tolerability between body weight groups. In the three AL body weight dosing groups (5 to < 15 kg, 15 to < 25 kg and 25 to < 35 kg), 80% of patients were aged 10-50 months, 46-100 months and 90-147 months, respectively.</p< <p<Conclusion</p< <p<Efficacy of AL in uncomplicated falciparum malaria is similar across body weight dosing groups as currently recommended in the label with no clinically relevant differences in safety or tolerability. AL dosing based on body weight remains advisable.</p<</subfield></datafield><datafield tag="653" ind1=" " ind2="0"><subfield code="a">Arctic medicine. 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Similar efficacy and safety of artemether-lumefantrine (Coartem<sup<®</sup<) in African infants and children with uncomplicated falciparum malaria across different body weight ranges

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