Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children

Malaria Journal

Volumn 7, Issue , 2008, Pages

  Falade, Catherine O ^a,b   Ogunkunle, Oluwatoyin O ^b   Dada Adegbola, Hannah O ^b   Falade, Adegoke G ^b   De Palacios, Patricia Ibarra ^c   Hunt, Philip ^d   Virtanen, Mailis ^c   Oduola, Ayoade M ^b   Salako, Lateef A ^a  

^a UNIVERSITY OF IBADAN   (Nigeria)

^b UNIVERSITY OF IBADAN   (Nigeria)

^c NOVARTIS PHARMA AG   (Switzerland)

^d NOVARTIS HORSHAM RESEARCH CENTRE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE; ARTEMETHER PLUS BENFLUMETOL; FANSIDAR; ARTEMETHER LUMEFANTRINE COMBINATION; ARTEMETHER-LUMEFANTRINE COMBINATION; ARTEMISININ DERIVATIVE; ETHANOLAMINE DERIVATIVE; FLUORENE DERIVATIVE;

ABDOMINAL DISTENSION; ANEMIA; ANOREXIA; ARTICLE; BODY WEIGHT; CATARRH; CHILD; CLINICAL TRIAL; CLONUS; COUGHING; DIARRHEA; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; DRUG SCREENING; DRUG TOLERABILITY; ELECTROCARDIOGRAM; EOSINOPHILIA; FEMALE; FEVER; GOLD STANDARD; HEPATOMEGALY; HUMAN; HYPERREFLEXIA; HYPOTHERMIA; INFANT; INSOMNIA; INTRAVASCULAR HEMOLYSIS; LEUKOPENIA; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MALE; MEDICAL RECORD; NIGERIA; NOSE DISEASE; OPEN STUDY; PARASITE; PARASITEMIA; PLASMA CLEARANCE; PLASMODIUM FALCIPARUM; POLYMERASE CHAIN REACTION; POPULATION RESEARCH; PRESCHOOL CHILD; QT INTERVAL; QT PROLONGATION; RASH; RECURRENT DISEASE; REGISTRATION; RESPIRATORY TRACT INFECTION; SPLENOMEGALY; TABLET; TREATMENT OUTCOME; VOMITING; ANIMAL; BLOOD; DRUG COMBINATION; DRUG EFFECT; PARASITOLOGY; TIME;

ANIMALS; ARTEMISININS; BLOOD; CHILD; CHILD, PRESCHOOL; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FEVER; FLUORENES; HUMANS; INFANT; MALARIA, FALCIPARUM; MALE; NIGERIA; PLASMODIUM FALCIPARUM; TIME FACTORS; TREATMENT OUTCOME;

EID: 58149279407     PISSN: None     EISSN: 14752875     Source Type: Journal    
DOI: 10.1186/1475-2875-7-246     Document Type: Article

References (24)

1. The mortality consequences of chloroquine use in Africa: Experience in Siaya, Western Kenya. JR Zucker Ruebush II TK C Obonyo J Otieno CC Campbell, Am J Trop Med Hyg 2003 68 386 390 12879851
2. The public health impact of chloroquine resistance in Africa. JF Trape, Am J Trop Med Hyg 2001 64 12 17 11425173
3. Phase II trial in China of a new rapidly acting and effective oral antimalarial CGP 56697 for the treatment of Plasmodium falciparum malaria. X Jiao GY Liu CO Shao X Zhao I Galliman C Royce, Southeast Asian J Trop Med Public Health 1999 28 3 476 481
4. A randomized, double blind, parallel-group, comparative safety and efficacy trial of oral co-artemether versus oral chloroquine in the treatment of acute uncomplicated Plasmodium falciparum malaria in adults in India. NA Kshirsagar NJ Gogtay NS Moorthy MR Gard SS Dalvi AR Chogle JS Sorabjee SN Marathe GH Tilve AD Bhatt SP Sane R Mull I Gathmann, Am J Trop Med Hyg 2000 62 402 408 11037786
5. Randomized comparison of artemether-benflumetol and artesunate-mefloquine in treatment of multidrug resistant falciparum malaria. M van Vugt A Brockman B Gemperli C Luxemburger I Gathmann C Royce T Slight S Looareesuwan NJ White F Nosten, Antimicrob Agents Chemother 1998 42 135 139 9449273
6. Efficacy of six-doses of artemether-lumefantrine (benflumetol) in multi drug resistant Plasmodium falciparum malaria. M van Vugt P Nilairataria B Gemperli I Fathman L Phaipun PA Broockman C Luxemburger NJ White F Nosten S Looareesuwan, Am J Trop Med Hyg 1999 60 936 942 10403324
7. A clinical and pharmacokinetic trial of six doses of artemether- lumefantrine for multidrug-resistance Plasmodium falciparum malaria in Thailand. G Lefèvre S Looareesuwan S Treeprasertsuk S Krudsood I Silachamroon R Mull R Bakshi, Am J Trop Med Hyg 2001 64 247 256 11463111
8. Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. M Makanga Z Premji C Falade K Karbwang EA Mueller K Andriano P Hunt P Ibarra de Palacios, Am J Trop Med Hyg 2006 74 991 998 16760509
9. Fatal neurotoxicity of artemether and arteether. TG Brewer SJ Grate JO Peggins PJ Weina JM Petras BS Levine MH Heifer BG Schuster, Am J Trop Med Hyg 1994 51 251 259 7943542
10. Artemisinin neurotoxicity: Neuropathology in rats and mechanistic studies in-vitro. S Kamchonwongpaisan P McKeever O Hossler H Ziffer SR Meshinick, Am J Trop Med Hyg 1996 56 1 7 12
11. Prolonged Q-Tc interval with halofantrine. A Castot P Rappaport P LeCoz, Lancet 1993 341 1541 10.1016/0140-6736(93)90685-A 8099419
12. ®) tablets (six-dose regimen) in African infants and children treatment of acute uncomplicated malaria. C Falade M Makanga Z Premji C-E Ortmann M Stockmeyer P Ibarra de Palacios, Trans R Soc Trop Med Hyg 2005 99 459 467 10.1016/j.trstmh.2004.09.013 15837358
13. The use of PCR genotyping in the assessment of recrudescence or reinfection after antimalarial drug treatment. G Snounou H Beck, Parasitol Today 1998 14 11 462 467 10.1016/S0169-4758(98)01340-4 17040849
14. I Abdu-Aguye UI Gebi A Wuyat M Agbo, An open-label uncontrolled trial confirming efficacy and safety of the 4-dose regimen of Coartem® in the treatment of acute Plasmodium falciparum malaria in patients aged > 2 years in Zaria Nigeria Report of a Clinical Trial, Novartis Pharma AG Nigeria study Report 2000
15. F Eke V Akhidue UE Ukiwo IJ Akosubo P Izuora PU Akpan M Ufford F Ugwumba A Dennis, Report of an open-label uncontrolled trial confirming efficacy and safety of a 4-dose regimen of Coartem® [artemether-lumefantrine (benflumetol)] in the treatment of acute Plasmodium falciparum malaria in children in Port Harcourt Novartis Pharma AG Nigeria study Report 2000
16. EN Ezedinachi E Ekanem-Ephraim N Ndifon V Amaechi AA Alaribe AB Bam, An open-label uncontrolled trial confirming efficacy and safety of the 4-dose regimen of Coartem® in the treatment of acute Plasmodium falciparum malaria in patients aged > 2 years in Calabar Nigeria Report of a Clinical Trial Novartis Pharma AG Nigeria study Report 2000
17. LA Salako TA Adewole BM Afolabi AG Mafe, An open-label uncontrolled trial confirming efficacy and safety of the 4-dose regimen of Coartem® in the treatment of acute Plasmodium falciparum malaria in patients aged > 2 years in Lagos Nigeria Report of a Clinical Trial. Novartis Pharma AG Nigeria study Report 2000
18. No evidence of cardiotoxicity during treatment with artemether- lumefantrine. M van Vugt F Ezzet F Nosten I Gathmann P Wilairatana S Looareesuwan NJ White, Am J Trop Med Hyg 1999 61 964 967 10674679
19. Comparison of the cardiac effects of the antimalarials co-artemether and halofantrine in healthy participants. M Bindschedler G Lefèvre P Degen A Sioufi, Am J Trop Med Hyg 2002 66 293 298 12139223
20. Efficacy and safety of CGP 56697 (artemether and benflumetol) compared with chloroquine to treat acute falciparum malaria in Tanzanian children aged 1-5 years. C Hatz S Abdulla R Mull D Schellenberg I Gathmann P Kibatala H Beck M Tanner C Royce, Trop Med Int Health 1998 3 498 504 10.1046/j.1365-3156.1998. 00250.x 9657513
21. A randomized controlled trial of artemether-benflumetol, a new antimalarial and sulfadoxine-pyrimethamine in the treatment of uncomplicated falciparum malaria in African children. LV Seidlein K Borjarg P Jones S Jaffar M Pinder I Grathman C Royce K McAdams B Greenwood, Am J Trop Med Hyg 1998 58 638 644 9598454
22. Artemether-lumefantrine versus artesunate plus amodiaquine for treating uncomplicated malaria in Nigeria: randomized controlled trial. M Meremikwu A Alaribe R Ejemot A Oyo-Ita J Ekenjoku C Nwachuckwu D Ordu E Ezedinachi, Malar J 2006 5 43 16704735 10.1186/1475-2875-5-43
23. How much fat is necessary to optimize lumefantrine oral bioavailability. EA Ashley K Stepniewska N Lindegardh A Anneberg AM Khan AI Brockman P Singhasivanon NJ White F Nosten, Trop Med Int Health 2007 12 195 198 17300625
24. FMOH, National Treatment guidelines for the treatment of malaria in Nigeria Federal Ministry of Health 2005