Randomized trial of artesunate+Amodiaquine, sulfadoxine-pyrimethamine+amodiaquine, chlorproguanal-dapsone and SP for malaria in pregnancy in Tanzania

PLoS ONE

Volumn 4, Issue 4, 2009, Pages

  Mutabingwa, Theonest K ^a,b   Muze, Kandi ^c,d   Ord, Rosalynn ^a   Briceño, Marnie ^e   Greenwood, Brian M ^a   Drakeley, Chris ^a   Whitty, Christopher J M ^a  

^a LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^b NATIONAL INSTITUTE FOR MEDICAL RESEARCH   (Tanzania)

^c Muheza Designated District Hospital   (Tanzania)

^d Muhimbile Medical Centre   (Tanzania)

^e UNIVERSITY OF WASHINGTON   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE; AMODIAQUINE PLUS ARTESUNATE; CHLORPROGUANIL PLUS DAPSONE; FANSIDAR; MOLECULAR MARKER; ARTEMISININ DERIVATIVE; ARTESUNATE; CHLORPROGUANIL DAPSONE; CHLORPROGUANIL-DAPSONE; DAPSONE; DRUG DERIVATIVE; PROGUANIL; PYRIMETHAMINE; SULFADOXINE; SULFADOXINE-PYRIMETHAMINE;

ABDOMINAL PAIN; ADULT; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DELIVERY; DIARRHEA; DIZZINESS; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG TREATMENT FAILURE; FEMALE; FOLLOW UP; HUMAN; MAJOR CLINICAL STUDY; MALARIA FALCIPARUM; MATERNAL MORTALITY; NAUSEA; OUTCOME ASSESSMENT; PREGNANCY; PREGNANCY OUTCOME; PREGNANT WOMAN; PRURITUS; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RISK BENEFIT ANALYSIS; SKIN TOXICITY; STILLBIRTH; TANZANIA; VOMITING; DRUG COMBINATION; MALARIA; PREGNANCY COMPLICATION;

ARTESUNATE;

ADULT; AMODIAQUINE; ARTEMISININS; CHLOROGUANIDE; DAPSONE; DRUG COMBINATIONS; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; MALARIA; PREGNANCY; PREGNANCY COMPLICATIONS, PARASITIC; PYRIMETHAMINE; SULFADOXINE; TANZANIA; YOUNG ADULT;

EID: 65249128053     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0005138     Document Type: Article

References (43)

1. Whitty CJM, Edmonds S, Mutabingwa TK (2005) Malaria in pregnancy. BJOG 112: 1189-95.
2. Desai M, ter Kuile FO, Nosten F, McGready R, Asamoa K, et al. (2007) Epidemiology and burden of malaria in pregnancy. Lancet Infect Dis 7: 93-104.
3. Watson-Jones D, Weiss HA, Changalucha JM, Todd J, Gumodoka B, et al. (2007) Adverse birth outcomes in United Republic of Tanzania - impact and prevention of maternal risk factors. Bull World Health Organ 85: 9-18.
4. Diagne N, Rogier C, Cisse B, Trape JF (1997) Incidence of clinical malaria in pregnant women exposed to intense perennial transmission. Trans R Soc Trop Med Hyg 92: 166-170.
5. Nosten F, McGready R, Mutabingwa TK (2007) Case management of malaria in pregnancy. Lancet Infect Dis 7: 118-25.
6. Steketee RW, Wirima JJ, Slutsker L, Khoromana CO, Breman JG, et al. (1996) Comparability of treatment groups and risk factors for parasitaemia at the first antenatal clinic visit in a study of malaria treatment and prevention in pregnancy in rural Malawi. Am J Trop Med Hyg 55(1 Suppl): 17-23.
7. Shulman CE, Graham WJ, Jilo H, Lowe BS, New L, et al. (1996) Malaria is an important cause of anaemia in primigravidae: evidence from a district hospital in coastal Kenya. Trans R Soc Trop Med Hyg 90: 535-539.
8. Mockenhaupt FP, Bedu-Addo G, von Gaertner C, Boye R, Fricke K, et al. (2006) Detection and clinical manifestation of placental malaria in southern Ghana. Malar J 5: 119.
9. WHO (2003) Assessment of the safety of artemisinin compounds in pregnancy. Report of two informal consultations convened by WHO in 2002. In WHO/CDS/MAL/2003.1094 WHO/RBM/TDR/Artemisinin/03.1. Geneva: World Health Organization.
10. Dellicour S, Hall S, Chandramohan D, Greenwood B (2007) The safety of artemisinins during pregnancy: a pressing question. Malar J 6: 15.
11. Greenwood B, Alonso P, ter Kuile FO, Hill J, Steketee RW (2007) Malaria in pregnancy: priorities for research. Lancet Infect Dis 7: 169-74.
12. Verhoeff FH, Brabin BJ, Chimsuku L, Kazembe P, Russell WB, et al. (1998) An evaluation of the effects of intermittent sulfadoxine-pyrimethamine treatment in pregnancy on parasite clearance and risk of low birthweight in rural Malawi. Ann Trop Med Para 92: 141-50.
13. Shulman CE, Dorman EK, Cutts F, Kawuondo K, Bulmer JN, et al. (1999) Intermittent sulfadoxine-pyrimethamine to prevent severe anaemia secondary to malaria in pregnancy: a randomised placebo-controlled trial. Lancet 353: 632-636.
14. D'Alessandro U, ter Kuile FO (2006) Amodiaquine, malaria, pregnancy: the old new drug. Lancet 368: 1306-7.
15. Tagbor HK, Chandramohan D, Greenwood BM (2007) The safety of amodiaquine use in pregnant women. Expert Opin Drug Saf 6: 631-5.
16. WHO (2006) Guidelines for the treatment of malaria. Geneva: World Health Organization.
17. Mutabingwa T, Nzila A, Mberu E, Nduati E, Winstanley P, et al. (2001) Chlorproguanil-dapsone for treatment of drug-resistant falciparum malaria in Tanzania. Lancet 358: 1218-23.
18. Keuter M, van Eijk A, Hoogstrate M, Raasveld M, van de Ree M, et al. (1990) Comparison of chloroquine, pyrimethamine and sulfadoxine, and chlorproguanil and dapsone as treatment for falciparum malaria in pregnant and nonpregnant women, Kakamega District, Kenya. BMJ 301: 466-70.
19. Kahn G (1985) Dapsone is safe during pregnancy. J Am Acad Dermatol 13: 838-9.
20. http://us.gsk.com/html/media-news/pressreleases/2008/2008∥essrelease_ 0014.htm.
21. McGready R, Cho T, Keo NK, Thwai KL, Villegas L, Looareesuwan S, et al. (2001) Artemisinin antimalarials in pregnancy: a prospective treatment study of 539 episodes of multidrug-resistant Plasmodium falciparum. Clin Infect Dis 33: 2009-16.
22. WHO (2007) Assessment of the safety of artemisinin compounds in pregnancy: Report of two joint informal consultations convened in 2006. Geneva: World Health Organization.
23. Deen JL, von Seidlein L, Pinder M, Walraven GE, Greenwood BM (2001) The safety of the combination artesunate and pyrimethamine-sulfadoxine given during pregnancy. Trans R Soc Trop Med Hyg 95: 424-8.
24. Staedke SG, Mpimbaza A, Kamya MR, Nzarubara BK, Dorsey G, et al. (2004) Combination treatments for uncomplicated falciparum malaria in Kampala, Uganda: randomised clinical trial. Lancet 364: 1950-7.
25. 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: 1474-80.
26. Tagbor H, Bruce J, Browne E, Randal A, Greenwood BM, et al. (2006) Efficacy, safety, and tolerability of amodiaquine plus sulphadoxine-pyrimethamine used alone or in combination for malaria treatment in pregnancy: a randomised trial. Lancet 368: 1349-56.
27. Obonyo CO, Juma EA, Ogutu BR, Vulule JM, Lau J (2007) Amodiaquine combined with sulfadoxine/pyrimethamine versus artemisinin-based combinations for the treatment of uncomplicated falciparum malaria in Africa: a metaanalysis. Trans R Soc Trop Med Hyg 101: 117-26.
28. Adjuik M, Agnamey P, Babiker A, Borrmann S, Brasseur P, et al. (2002) Amodiaquine-artesunate versus amodiaquine for uncomplicated Plasmodium falciparum malaria in African children: a randomised, multicentre trial. Lancet 359: 1365-72.
29. Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, et al. (2005) Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis 41: 1079-86.
30. WHO (2000) Management of Severe Malaria: a practical Handbook. Geneva: World Health Organization.
31. Mendez F, Munoz A, Plowe CV (2006) Use of area under the curve to characterize transmission potential after antimalarial treatment. Am J Trop Med Hyg 75: 640-646.
32. Snounou G, Viriyakosol S, Zhu XP, Jarra W, Pinheiro L, et al. (1993) High sensitivity of detection of human malaria parasites by the use of nested polymerase chain reaction. Mol Biochem Parasitol 61: 315-20.
33. Ward SA, Sevene EJ, Hastings IM, Nosten F, McGready R (2007) Antimalarial drugs and pregnancy: safety, pharmacokinetics, and pharmacovigilance. Lancet Infect Dis 7: 136-44.
34. White NJ (2007) Cardiotoxicity of antimalarial drugs. Lancet Infect Dis 7: 549-58.
35. Bukirwa H, Garner P, Critchley JA (2004) Chlorproguanil-dapsone for treating uncomplicated malaria. Cochrane Database of Systematic Reviews Issue 4. Art. No.: CD004387. DOI: 10.1002/14651858.CD004387.pub2.
36. Wangboonskul J, White NJ, Nosten F, ter Kuile F, Moody RR, et al. (1993) Single dose pharmacokinetics of proguanil and its metabolites in pregnancy. Eur J Clin Pharmacol 44: 247-51.
37. Vallely A, Vallely L, Changalucha J, Greenwood B, Chandramohan D (2007) Intermittent preventive treatment for malaria in pregnancy in Africa: what's new, what's needed? Malar J 6: 16.
38. Tagbor H, Bruce J, Ord R, Randall A, Browne E, Greenwood BM, et al. (2007) Comparison of the therapeutic efficacy of chloroquine and sulphadoxinepyremethamine in children and pregnant women. Trop Med Int Health 12: 1288-97.
39. Garner P, Gulmezoglu AM (2006) Drugs for preventing malaria in pregnant women. Cochrane Database Syst Rev 4: CD000169.
40. ter Kuile FO, van Eijk AM, Filler SJ (2007) Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review. JAMA 297: 2603-16.
41. Brentlinger PE, Behrens CB, Micek MA (2006) Challenges in the concurrent management of malaria and HIV in pregnancy in sub-Saharan Africa. Lancet Infect Dis 6: 100-11.
42. Slutsker L, Marston BJ (2007) HIV and malaria: interactions and implications. Curr Opin Infect Dis 20(1): 3-10.
43. McGready R, Stepniewska K, Lindegardh N, Ashley EA, La Y, et al. (2006) The pharmacokinetics of artemether and lumefantrine in pregnant women with uncomplicated falciparum malaria. Eur J Clin Pharmacol 62: 1021-31.