A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in african children: A randomized trial

PLoS Medicine

Volumn 8, Issue 11, 2011, Pages

  The Four Artemisinin Based Combinations Study group, ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE PLUS ARTESUNATE; ARTEMETHER PLUS BENFLUMETOL; ARTESUNATE; ARTESUNATE PLUS CHLORPROGUANIL PLUS DAPSONE; CHLORPROGUANIL PLUS DAPSONE; COARSUCAM; DIHYDROARTEMISININ PLUS PIPERAQUINE; UNCLASSIFIED DRUG;

AFRICA; ARTICLE; CHILD; CHILD HEALTH; CONTROLLED STUDY; DRUG EFFICACY; DRUG FORMULATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; FOLLOW UP; HUMAN; INFANT; MAJOR CLINICAL STUDY; MALARIA; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; POLYMERASE CHAIN REACTION; PRESCHOOL CHILD; RANDOMIZED CONTROLLED TRIAL; TREATMENT FAILURE;

ADULT; AFRICA SOUTH OF THE SAHARA; AMODIAQUINE; ANTIMALARIALS; ARTEMISININS; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; MALARIA, FALCIPARUM; MALE;

EID: 82555195187     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001119     Document Type: Article

References (56)

1. Prudhomme O'Meara W, Nekesa Mangeni J, Steketee R, Greenwood B, (2010) Changes in the burden of malaria in sub-Saharan Africa. Lancet Infect Dis 10: 545-555.
2. World Health Organization (2009) World malaria report 2009 Geneva World Health Organization.
3. Sharp BL, Kleinschmidt I, Streat E, Maharaj R, Barnes KI, et al. (2007) Seven years of regional malaria control collaboration-Mozambique, South Africa, and Swaziland. Am J Trop Med Hyg 76: 42-47.
4. Sharp BL, Ridl FC, Govender D, Kuklinski J, Kleinschmidt I, (2007) Malaria vector control by indoor residual insecticide spraying on the tropical island of Bioko, Equatorial Guinea. Malar J 6: 52.
5. Nyarango PM, Gebremeskel T, Mebrahtu G, Mufunda J, Abdulmumini U, et al. (2006) A steep decline of malaria morbidity and mortality trends in Eritrea between 2000 and 2004: the effect of combination of control methods. Malar J 5: 33.
6. Bhattarai A, Ali SS, Kachur SP, Mårtensson A, Abbas AK, et al. (2007) Impact of artemisinin-based combination therapy and insecticide-treated nets on malaria burden in Zanzibar. PLoS Med 4: e309 doi:10.1371/journal.pmed.0040309.
7. Fegan GW, Noor AM, Akhwale WS, Cousens S, Snow RW, (2007) Effect of expanded insecticide-treated bednet coverage on child survival in rural Kenya: a longitudinal study. Lancet 370: 1035-1039.
8. Nosten F, White NJ, (2007) Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 77 (Suppl 6): 181-192.
9. Bosman A, Mendis KN, (2007) A major transition in malaria treatment: the adoption and deployment of artemisinin-based combination therapies. Am J Trop Med Hyg 77 (Suppl 6): 193-197.
10. Bathurst I, Hentschel C, (2006) Medicines for Malaria Venture: sustaining antimalarial drug development. Trends Parasitol 22: 301-307.
11. D'Alessandro U, (2009) Existing antimalarial agents and malaria-treatment strategies. Expert Opin Pharmacother 10: 1291-1306.
12. World Health Organization (2010) Guidelines for the treatment of malaria, 2nd edition Geneva World Health Organization.
13. Medicine for Malaria Venture (2007) Orphan drug status for MMV drug DHA-piperaquine. Available: http://www.mmv.org/newsroom/news/orphan-drug-status-mmv-drug-dha-piperaq uine. Accessed 12 December 2010.
14. Bassat Q, Mulenga M, Tinto H, Piola P, Borrmann S, et al. (2009) Dihydroartemisinin-piperaquine and artemether-lumefantrine for treating uncomplicated malaria in African children: a randomised, non-inferiority trial. PLoS ONE 4: e7871 doi:10.1371/journal.pone.0007871.
15. Valecha N, Phyo AP, Mayxay M, Newton PN, Krudsood S, et al. (2010) An open-label, randomised study of dihydroartemisinin-piperaquine versus artesunate-mefloquine for falciparum malaria in Asia. PLoS ONE 5: e11880 doi:10.1371/journal.pone.0011880.
16. World Health Organization (2010) Global report on antimalarial drug efficacy and drug resistance: 2000-2010 Geneva World Health Organization.
17. Luzzatto L, (2010) The rise and fall of the antimalarial Lapdap: a lesson in pharmacogenetics. Lancet 376: 739-741.
18. World Health Organization Communicable Diseases Cluster (2000) Severe falciparum malaria. Trans R Soc Trop Med Hyg 94 (Suppl 1): S1-S90.
19. World Health Organization (2008) Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations Geneva World Health Organization.
20. Plowe CV, Djimde A, Bouare M, Doumbo O, Wellems TE, (1995) Pyrimethamine and proguanil resistance-conferring mutations in Plasmodium falciparum dihydrofolate reductase: polymerase chain reaction methods for surveillance in Africa. Am J Trop Med Hyg 52: 565-568.
21. World Health Organization (2003) Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria Geneva World Health Organization.
22. Stepniewska K, Taylor WR, Mayxay M, Price R, Smithuis F, et al. (2004) In vivo assessment of drug efficacy against Plasmodium falciparum malaria: duration of follow-up. Antimicrob Agents Chemother 48: 4271-4280.
23. Engels EA, Schmid CH, Terrin N, Olkin I, Lau J, (2000) Heterogeneity and statistical significance in meta-analysis: an empirical study of 125 meta-analyses. Stat Med 19: 1707-1728.
24. Newcombe RG, (1998) Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 17: 873-890.
25. Premji Z, Umeh RE, Owusu-Agyei S, Esamai F, Ezedinachi EU, et al. (2009) Chlorproguanil-dapsone-artesunate versus artemether-lumefantrine: A randomized, double-blind phase III trial in African children and adolescents with uncomplicated Plasmodium falciparum malaria. PLoS ONE 4: e6682 doi:10.1371/journal.pone.0006682.
26. Tshefu AK, Gaye O, Kayentao K, Thompson R, Bhatt KM, et al. (2010) Efficacy and safety of a fixed-dose oral combination of pyronaridine-artesunate compared with artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria: a randomised non-inferiority trial. Lancet 375: 1457-1467.
27. Ndiaye JL, Randrianarivelojosia M, Sagara I, Brasseur P, Ndiaye I, et al. (2009) Randomized, multicentre assessment of the efficacy and safety of ASAQ-a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria. Malar J 8: 125 doi:10.1186/1475-2875-8-125.
28. Faye B, Offianan AT, Ndiaye JL, Tine RC, Toure W, et al. (2010) Efficacy and tolerability of artesunate-amodiaquine (Camoquin plus) versus artemether-lumefantrine (Coartem) against uncomplicated Plasmodium falciparum malaria: multisite trial in Senegal and Ivory Coast. Trop Med Intern Health 15: 608-613.
29. Dorsey G, Staedke S, Clark TD, Ndjama-Meya D, Nzarubara B, et al. (2007) Combination therapy for uncomplicated falciparum malaria in Ugandan children: a randomized trial. JAMA 297: 2210-2219.
30. Clark TD, Njama-Meya D, Nzarubara B, Maiteki-Sebuguzi C, Greenhouse B, et al. (2010) Incidence of malaria and efficacy of combination antimalarial therapies over 4 years in an urban cohort of Ugandan children. PLoS ONE 5: e11759 doi:10.1371/journal.pone.0011759.
31. Mutabingwa TK, Anthony D, Heller A, Hallett R, Ahmed J, et al. (2005) Amodiaquine alone, amodiaquine+sulfadoxine-pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Lancet 365: 1474-1480.
32. Douglas NM, Anstey NM, Angus BJ, Nosten F, Price RN, (2006) Artemisinin combination therapy for vivax malaria. Lancet Infect Dis 10: 405-416.
33. Simpson JA, Hughes D, Manyando C, Bojang K, Aarons L, et al. (2006) Population pharmacokinetic and pharmacodynamic modelling of the antimalarial chemotherapy chlorproguanil/dapsone. Br J Clin Pharmacol 61: 289-300.
34. Okello PE, Van Bortel W, Byaruhanga AM, Correwyn A, Roelants P, et al. (2006) Variation in malaria transmission intensity in seven sites throughout Uganda. Am J Trop Med Hyg 75: 219-225.
35. Arinaitwe E, Sandison TG, Wanzira H, Kakuru A, Homsy J, et al. (2009) Artemether-lumefantrine versus dihydroartemisinin-piperaquine for falciparum malaria: a longitudinal, randomized trial in young Ugandan children. Clin Infect Dis 49: 1629-1637.
36. Stepniewska K, White NJ, (2008) Pharmacokinetic determinants of the window of selection for antimalarial drug resistance. Antimicrob Agents Chemother 52: 1589-1596.
37. Smithuis F, Kyaw MK, Phe O, Aye KZ, Htet L, et al. (2006) Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison. Lancet 367: 2075-2085.
38. Grande T, Bernasconi A, Erhart A, Gamboa D, Casapia M, et al. (2007) A randomised controlled trial to assess the efficacy of dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Peru. PLoS ONE 2: e1101 doi:10.1371/journal.pone.0001101.
39. Mens PF, Sawa P, van Amsterdam SM, Versteeg I, Omar SA, et al. (2008) A randomized trial to monitor the efficacy and effectiveness by QT-NASBA of artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment and transmission control of uncomplicated Plasmodium falciparum malaria in western Kenya. Malar J 7: 237 doi:10.1186/1475-2875-7-237.
40. Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, et al. (2007) Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet 369: 757-765.
41. Smithuis F, Kyaw KM, Phe O, Win T, Aung PP, et al. (2010) Effectiveness of five artemisinin combination regimens with or without primaquine in uncomplicated falciparum malaria: an open-label randomised trial. Lancet Infect Dis 10: 673-681.
42. Ouédraogo AL, Bousema T, Schneider P, de Vlas SJ, Ilboudo-Sanogo E, et al. (2009) Substantial contribution of submicroscopical Plasmodium falciparum gametocyte carriage to the infectious reservoir in an area of seasonal transmission. PLoS ONE 4: e8410 doi:10.1371/journal.pone.0008410.
43. Bousema TJ, Schneider P, Gouagna LC, Drakeley CJ, Tostmann A, et al. (2006) Moderate effect of artemisinin-based combination therapy on transmission of Plasmodium falciparum. J Infect Dis 193: 1151-1159.
44. Okell LC, Drakeley CJ, Ghani AC, Bousema T, Sutherland CJ, (2008) Reduction of transmission from malaria patients by artemisinin combination therapies: a pooled analysis of six randomized trials. Malar J 7: 125 doi:10.1186/1475-2875-7-125.
45. Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, et al. (2010) In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (g6pd a-) individuals. Antimicrob Agents Chemother 54: 1762-1768.
46. Tinto H, Sanou B, Erhart A, D'Alessandro U, Ouédraogo JB, et al. (2006) In vivo sensitivity of Plasmodium falciparum to chloroquine and sulfadoxine-pyrimethamine in the Bobo Dioulasso region (1998-2001): risk factors associated with treatment failures to the two drugs. Bull Soc Pathol Exot 99: 161-165.
47. Borrmann S, Binder RK, Adegnika AA, Missinou MA, Issifou S, et al. (2002) Reassessment of the resistance of Plasmodium falciparum to chloroquine in Gabon: implications for the validity of tests in vitro vs. in vivo. Trans R Soc Trop Med Hyg 96: 660-663.
48. Lell B, Lehman LG, Schmidt-Ott JR, Sturchler D, Handschin J, et al. (1998) Malaria chemotherapy trial at a minimal effective dose of mefloquine/sulfadoxine/pyrimethamine compared with equivalent doses of sulfadoxine/pyrimethamine or mefloquine alone. Am J Trop Med Hyg 58: 619-624.
49. Ezedinachi E, (1996) In vivo efficacy of chloroquine, halofantrine, pyrimethamine-sulfadoxine and ginghaosu (artesunate) in the treatment of malaria in Calabar, Nigeria. Cent Afr J Med 42: 109-111.
50. Mulenga M, Malunga P, Bennett S, Thuma P, Shulman C, et al. (2006) Folic acid treatment of Zambian children with moderate to severe malaria anemia. Am J Trop Med Hyg 74: 986-990.
51. Tinto H, (2005) Plasmosium falciparum drug resistance: molecular markers, in vivo and in vitro tests [PhD dissertation] Antwerp University of Antwerp.
52. Talisuna AO, Langi P, Bakyaita N, Egwang T, Mutabingwa TK, et al. (2002) Intensity of malaria transmission, antimalarial-drug use and resistance in Uganda: what is the relationship between these three factors? Trans R Soc Trop Med Hyg 96: 310-317.
53. Talisuna AO, Okello PE, Erhart A, Coosemans M, D'Alessandro U, (2007) Intensity of malaria transmission and the spread of Plasmodium falciparum resistant malaria: a review of epidemiologic field evidence. Am J Trop Med Hyg 77 (Suppl 6): 170-180.
54. Alonso PL, Sacarlal J, Aponte JJ, Leach A, Macete E, et al. (2004) Efficacy of the RTS,S/AS02A vaccine against Plasmodium falciparum infection and disease in young African children: randomised controlled trial. Lancet 364: 1411-1420.
55. Abacassamo F, Enosse S, Aponte JJ, Gómez-Olivé FX, Quintó L, et al. (2004) Efficacy of chloroquine, amodiaquine, sulphadoxine-pyrimethamine and combination therapy with artesunate in Mozambican children with non-complicated malaria. Trop Med Int Health 9: 200-208.
56. Legros D, Johnson K, Houpikian P, Makanga M, Kabakyenga JK, et al. (2002) Clinical efficacy of chloroquine and sulfadoxine-pyrimethamine in children under five from southwestern Uganda with uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 96: 199-201.