Efficacy and safety of artemether-lumefantrine compared with quinine in pregnant women with uncomplicated Plasmodium falciparum malaria: an open-label, randomised, non-inferiority trial

The Lancet Infectious Diseases

Volumn 10, Issue 11, 2010, Pages 762-769

  Piola, Patrice ^a,d   Nabasumba, Carolyn ^a   Turyakira, Eleanor ^a,b   Dhorda, Mehul ^a,c   Lindegardh, Niklas ^d   Nyehangane, Dan ^a   Snounou, Georges ^e,f   Ashley, Elizabeth A ^a,g   McGready, Rose ^c,d,h   Nosten, Francois ^c,d,h   Guerin, Philippe J ^a,d  

^a EPICENTRE   (France)

^b MBARARA UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Uganda)

^c MAHIDOL UNIVERSITY   (Thailand)

^d UNIVERSITY OF OXFORD   (United Kingdom)

^e INSERM   (France)

^f SORBONNE UNIVERSITÉ   (France)

^g IMPERIAL COLLEGE HEALTHCARE NHS TRUST   (United Kingdom)

^h SHOKLO MALARIA RESEARCH UNIT   (Thailand)

Author keywords

[No Author keywords available]

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; QUININE;

ABDOMINAL PAIN; ADOLESCENT; ADULT; ANOREXIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIZZINESS; DRUG EFFICACY; DRUG INDUCED HEADACHE; DRUG SAFETY; EOSINOPHIL; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; HEART DISEASE; HUMAN; LYMPHOCYTOPENIA; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MATERNAL MORTALITY; NAUSEA; NEWBORN DEATH; POLYDACTYLY; POLYMERASE CHAIN REACTION; PREGNANT WOMAN; PRENATAL CARE; PRIORITY JOURNAL; QT PROLONGATION; RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL; SECOND TRIMESTER PREGNANCY; SIDE EFFECT; SPONTANEOUS ABORTION; THIRD TRIMESTER PREGNANCY; THROMBOCYTE; TINNITUS; TREATMENT OUTCOME; VOMITING; WEAKNESS;

ADOLESCENT; ADULT; ANIMALS; ANTIMALARIALS; ARTEMISININS; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; MALARIA, FALCIPARUM; PLASMODIUM FALCIPARUM; POLYMERASE CHAIN REACTION; PREGNANCY; PREGNANCY COMPLICATIONS, INFECTIOUS; QUININE; TREATMENT OUTCOME; UGANDA; YOUNG ADULT;

EID: 78049359991     PISSN: 14733099     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1473-3099(10)70202-4     Document Type: Article

References (36)

1. Desai M, ter Kuile FO, Nosten F, et al. Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis 2007, 7:93-104.
2. Dafallah SE, Elhadi H Perinatal mortality rate in a teaching hospital in Sudan: review of 15 years. Saudi Med J 2004, 25:242-243.
3. Rutgers S Two years maternal mortality in Matebeleland north Province, Zimbabwe. Cent Afr J Med 2001, 47:39-43.
4. Steketee RW, Nahlen BL, Parise ME, Menendez C The burden of malaria in pregnancy in malaria-endemic areas. Am J Trop Med Hyg 2001, 64(1-2 suppl):28-35.
5. Verhoeff FH, Brabin BJ, Chimsuku L, Kazembe P, Broadhead RL An analysis of the determinants of anaemia in pregnant women in rural Malawi-a basis for action. Ann Trop Med Parasitol 1999, 93:119-133.
6. Guyatt HL, Snow RW Impact of malaria during pregnancy on low birth weight in sub-Saharan Africa. Clin Microbiol Rev 2004, 17:760-769.
7. le Cessie S, Verhoeff FH, Mengistie G, Kazembe P, Broadhead R, Brabin BJ Changes in haemoglobin levels in infants in Malawi: effect of low birth weight and fetal anaemia. Arch Dis Child Fetal Neonatal Ed 2002, 86:F182-F187.
8. Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, Chandramohan D Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet 2006, 368:1349-1356.
9. Nosten F, White NJ Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 2007, 77(6 suppl):181-192.
10. McGready R, Cho T, Samuel, et al. Randomized comparison of quinine-clindamycin versus artesunate in the treatment of falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 2001, 95:651-656.
11. Fungladda W, Honrado ER, Thimasarn K, et al. Compliance with artesunate and quinine + tetracycline treatment of uncomplicated falciparum malaria in Thailand. Bull World Health Organ 1998, 76(suppl 1):59-66.
12. Adam I, Ali DM, Noureldien W, Elbashir MI Quinine for the treatment of chloroquine-resistant Plasmodium falciparum malaria in pregnant and non-pregnant Sudanese women. Ann Trop Med Parasitol 2005, 99:427-429.
13. Guidelines for the treatment of malaria 2010, WHO, World Health Organization, Geneva, (accessed May 1, 2010). http://whqlibdoc.who.int/publications/2010/9789241547925_eng.pdf, 2nd edn.
14. McGready R, Cho T, Cho JJ, et al. Artemisinin derivatives in the treatment of falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 1998, 92:430-433.
15. McGready R, Brockman A, Cho T, et al. Randomized comparison of mefloquine-artesunate versus quinine in the treatment of multidrug-resistant falciparum malaria in pregnancy. Trans R Soc Trop Med Hyg 2000, 94:689-693.
16. McGready R, Tan SO, Ashley EA, et al. A randomised controlled trial of artemether-lumefantrine versus artesunate for uncomplicated Plasmodium falciparum treatment in pregnancy. PLoS Med 2008, 5:e253.
17. Sowunmi A, Fehintola FA, Ogundahunsi OA, Arowojolu AO, Oduola AM Efficacy of chloroquine plus chlorpheniramine in chloroquine-resistant falciparum malaria during pregnancy in Nigerian women: a preliminary study. J Obstet Gynaecol 1998, 18:524-527.
18. Adam I, Ali DM, Abdalla MA Artesunate plus sulfadoxine-pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria during pregnancy in eastern Sudan. Trans R Soc Trop Med Hyg 2006, 100:632-635.
19. Mutabingwa TK, Muze K, Ord R, et al. Randomized trial of artesunate+amodiaquine, sulfadoxine-pyrimethamine+amodiaquine, chlorproguanal-dapsone and SP for malaria in pregnancy in Tanzania. PLoS One 2009, 4:e5138.
20. Kalilani L, Mofolo I, Chaponda M, et al. A randomized controlled pilot trial of azithromycin or artesunate added to sulfadoxine-pyrimethamine as treatment for malaria in pregnant women. PLoS One 2007, 2:e1166.
21. McGready R, Tan SO, Ashley EA, et al. A randomised controlled trial of artemether-lumefantrine versus artesunate for uncomplicated Plasmodium falciparum treatment in pregnancy. PLoS Med 2008, 5:e253.
22. Methods and techniques for clinical trials on antimalarial drug efficacy: genotyping to identify parasite populations Medicines for Malaria Venture, WHOWHO, (accessed March 2, 2010). http://whqlibdoc.who.int/publications/2008/9789241596305_eng.pdf.
23. Annerberg A, Singtoroj T, Tipmanee P, White NJ, Day NP, Lindegardh N High throughput assay for the determination of lumefantrine in plasma. J Chromatogr B Analyt Technol Biomed Life Sci 2005, 822:330-333.
24. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria WHO, (accessed May 1, 2010). http://whqlibdoc.who.int/hq/2003/WHO_HTM_RBM_2003.50.pdf.
25. ICH harmonised tripartite guideline: guideline for good clinical practice E6(R1) International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use, (assessed Sept 17, 2010). http://www.ich.org/LOB/media/MEDIA482.pdf.
26. Verret WJ, Dorsey G, Nosten F, Price RN The effect of varying analytical methods on estimates of anti-malarial clinical efficacy. Malar J 2009, 8:77.
27. McGready R, Davison BB, Stepniewska K, et al. The effects of Plasmodium falciparum and P vivax infections on placental histopathology in an area of low malaria transmission. Am J Trop Med Hyg 2004, 70:398-407.
28. Price RN, Cassar C, Brockman A, et al. The pfmdr1 gene is associated with a multidrug-resistant phenotype in Plasmodium falciparum from the western border of Thailand. Antimicrob Agents Chemother 1999, 43:2943-2949.
29. Nosten F, McGready R, Simpson JA, et al. Effects of Plasmodium vivax malaria in pregnancy. Lancet 1999, 354:546-549.
30. Ashley EA, Pinoges L, Turyakira E, et al. Different methodological approaches to the assessment of in vivo efficacy of three artemisinin-based combination antimalarial treatments for the treatment of uncomplicated falciparum malaria in African children. Malar J 2008, 7:154.
31. Hanscheid T, Langin M, Lell B, et al. Full blood count and haemozoin-containing leukocytes in children with malaria: diagnostic value and association with disease severity. Malar J 2008, 7:109.
32. Clark RL Embryotoxicity of the artemisinin antimalarials and potential consequences for use in women in the first trimester. Reprod Toxicol 2009, 28:285-296.
33. Li GQ, Guo XB, Fu LC, Jian HX, Wang XH Clinical trials of artemisinin and its derivatives in the treatment of malaria in China. Trans R Soc Trop Med Hyg 1994, 88(suppl 1):S5-S6.
34. White NJ, van Vugt M, Ezzet F Clinical pharmacokinetics and pharmacodynamics and pharmacodynamics of artemether-lumefantrine. Clin Pharmacokinet 1999, 37:105-125.
35. Tarning J, McGready R, Lindegardh N, et al. Population pharmacokinetics of lumefantrine in pregnant women treated with artemether-lumefantrine for uncomplicated Plasmodium falciparum malaria. Antimicrob Agents Chemother 2009, 53:3837-3846.
36. Barnes KI, Watkins WM, White NJ Antimalarial dosing regimens and drug resistance. Trends Parasitol 2008, 24:127-134.