Intermittent preventive treatment in infants for the prevention of malaria in rural western Kenya: A randomized, double-blind placebo-controlled trial

PLoS ONE

Volumn 5, Issue 4, 2010, Pages

  Odhiambo, Frank O ^a   Hamel, Mary J ^a,b   Williamson, John ^b   Lindblade, Kim ^b   ter Kuile, Feiko O ^c   Peterson, Elizabeth ^d   Otieno, Peter ^a   Kariuki, Simon ^a   Vulule, John ^a   Slutsker, Laurence ^b   Newman, Robert D ^b  

^a KENYA MEDICAL RESEARCH INSTITUTE   (Kenya)

^b CENTERS FOR DISEASE CONTROL AND PREVENTION   (United States)

^c LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

^d VERMONT DEPARTMENT OF HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMODIAQUINE; ARTESUNATE; CHLORPROGUANIL PLUS DAPSONE; FANSIDAR; FERROUS SULFATE; PLACEBO; ANTIMALARIAL AGENT; ARTEMISININ DERIVATIVE; CHLOROGUANIL, DAPSONE DRUG COMBINATION; DAPSONE; DRUG DERIVATIVE; PROGUANIL; PYRIMETHAMINE; PYRIMETHAMINE PLUS SULFADOXINE; SULFADOXINE; SULFADOXINE-PYRIMETHAMINE;

ANEMIA; ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMOLYSIS; HUMAN; INCIDENCE; INFANT; KENYA; MAJOR CLINICAL STUDY; MALARIA; MALARIA CONTROL; MALE; PATIENT COMPLIANCE; PROTECTION; RANDOMIZED CONTROLLED TRIAL; RURAL AREA; SKIN DISEASE; UNSPECIFIED SIDE EFFECT; DRUG COMBINATION; METHODOLOGY; PREMEDICATION; TREATMENT OUTCOME;

ARTESUNATE;

ANEMIA; ANTIMALARIALS; ARTEMISININS; DAPSONE; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; HUMANS; INCIDENCE; INFANT; KENYA; MALARIA; PREMEDICATION; PROGUANIL; PYRIMETHAMINE; SULFADOXINE; TREATMENT OUTCOME;

EID: 77952247720     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0010016     Document Type: Article

References (59)

1. Rowe AK, Rowe SY, Snow RW, Korenromp EL, Schellenberg JR, et al. (2006) The burden of malaria mortality among African children in the year 2000. Int J Epidemiol 35: 691-704.
2. WHO, UNICEF (2005) World Malaria Report 2005.
3. Breman JG, Egan A, Keusch GT (2001) The intolerable burden of malaria: a new look at the numbers. Am J Trop Med Hyg 64: iv-vii.
4. Murphy SC, Breman JG (2001) Gaps in the childhood malaria burden in Africa: cerebral malaria, neurological sequelae, anemia, respiratory distress, hypoglycemia, and complications of pregnancy. Am J Trop Med Hyg 64: 57-67.
5. Shiff C, Checkley W, Winch P, Premji Z, Minjas J, et al. (1996) Changes in weight gain and anaemia attributable to malaria in Tanzanian children living under holoendemic conditions. Trans R Soc Trop Med Hyg 90: 262-265.
6. McElroy PD, Lal AA, Hawley WA, Bloland PB, Kuile FO, et al. (1999) Analysis of repeated hemoglobin measures in full-term, normal birth weight Kenyan children between birth and four years of age. III. The Asemobo Bay Cohort Project. Am J Trop Med Hyg 61: 932-940.
7. Schellenberg D, Menendez C, Kahigwa E, Aponte J, Vidal J, et al. (2001) Intermittent treatment for malaria and anaemia control at time of routine vaccinations in Tanzanian infants: a randomised, placebo-controlled trial. Lancet 357: 1471-1477.
8. Massaga JJ, Kitua AY, Lemnge MM, Akida JA, Malle LN, et al. (2003) Effect of intermittent treatment with amodiaquine on anaemia and malarial fevers in infants in Tanzania: a randomised placebo-controlled trial. Lancet 361: 1853-1860.
9. Chandramohan D, Owusu-Agyei S, Carneiro I, Awine T, Amponsa-Achiano K, et al. (2005) Cluster randomised trial of intermittent preventive treatment for malaria in infants in area of high, seasonal transmission in Ghana. Bmj 331: 727-733.
10. Macete E, Aide P, Aponte JJ, Sanz S, Mandomando I, et al. (2006) Intermittent preventive treatment for malaria control administered at the time of routine vaccinations in mozambican infants: a randomized, placebo-controlled trial. J Infect Dis 194: 276-285.
11. Kobbe R, Kreuzberg C, Adjei S, Thompson B, Langefeld I, et al. (2007) A randomized controlled trial of extended intermittent preventive antimalarial treatment in infants. Clin Infect Dis 45: 16-25.
12. Mockenhaupt FP, Reither K, Zanger P, Roepcke F, Danquah I, et al. (2007) Intermittent preventive treatment in infants as a means of malaria control: a randomized, double-blind, placebo-controlled trial in northern Ghana. Antimicrob Agents Chemother 51: 3273-3281.
13. Grobusch MP, Lell B, Schwarz NG, Gabor J, Dornemann J, et al. (2007) Intermittent Preventive Treatment against Malaria in Infants in Gabon-A Randomized, Double-Blind, Placebo-Controlled Trial. J Infect Dis 196: 1595-1602.
14. IOM (2008) Assessment of the Role of Intermittent Preventive Treatment for Malaria in Infants: Letter Report. Washington DC: Institute of Medicine. 0-309-11909-X 0-309-11909-X: 80.
15. Gosling RD, Gesase S, Mosha JF, Carneiro I, Hashim R, et al. (2009) Protective efficacy and safety of three antimalarial regimens for intermittent preventive treatment for malaria in infants: a randomised, double-blind, placebo-controlled trial. Lancet 374: 1521-1532.
16. Vreugdenhil CJ, Scheper FY, Hoogstraatte SR, Smolders M, Gikunda S, et al. (2004) Comparison of the parasitologic efficacy of amodiaquine and ulfadoxinepyrimethamine in the treatment of Plasmodium falciparum malaria in the Bungoma District of western Kenya. Am J Trop Med Hyg 71: 537-541.
17. Obonyo CO, Ochieng F, Taylor WR, Ochola SA, Mugitu K, et al. (2003) Artesunate plus sulfadoxine-pyrimethamine for uncomplicated malaria in Kenyan children: a randomized, double-blind, placebo-controlled trial. Trans R Soc Trop Med Hyg 97: 585-591.
18. White NJ (2005) Intermittent presumptive treatment for malaria. PLoS Med 2: e3.
19. Schellenberg D, Menendez C, Aponte JJ, Kahigwa E, Tanner M, et al. (2005) Intermittent preventive antimalarial treatment for Tanzanian infants: follow-up to age 2 years of a randomised, placebo-controlled trial. Lancet 365: 1481-1483.
20. Cairns M, Carneiro I, Milligan P, Owusu-Agyei S, Awine T, et al. (2008) Duration of protection against malaria and anaemia provided by intermittent preventive treatment in infants in Navrongo, Ghana. PLoS ONE 3: e2227.
21. May J, Adjei S, Busch W, Gabor JJ, Issifou S, et al. (2008) Therapeutic and prophylactic effect of intermittent preventive anti-malarial treatment in infants (IPTi) from Ghana and Gabon. Malar J 7: 198.
22. Egan A, Crawley J, Schellenberg D (2005) Intermittent preventive treatment for malaria control in infants: moving towards evidence-based policy and public health action. Trop Med Int Health 10: 815-817.
23. Schellenberg D, Cisse B, Menendez C (2006) The IPTi Consortium: research for policy and action. Trends Parasitol 22: 296-300.
24. Adazu K, Lindblade KA, Rosen DH, Odhiambo F, Ofware P, et al. (2005) Health and demographic surveillance in rural western Kenya: a platform for evaluating interventions to reduce morbidity and mortality from infectious diseases. Am J Trop Med Hyg 73: 1151-1158.
25. Phillips-Howard PA, Nahlen BL, Alaii JA, ter Kuile FO, Gimnig JE, et al. (2003) The efficacy of permethrin-treated bed nets on child mortality and morbidity in western Kenya I. Development of infrastructure and description of study site. A J Trop Med Hyg 68: 3-9.
26. Beier JC, Perkins PV, Onyango FK, Gargan TP, Oster CN, et al. (1990) Characterization of malaria transmission by Anopheles (Diptera: Culicidae) in western Kenya in preparation for malaria vaccine trials. J Med Entomol 27: 570-577.
27. Gimnig JE, Vulule JM, Lo TQ, Kamau L, Kolczak MS, et al. (2003) Impact of permethrin-treated bed nets on entomologic indices in an area of intense yearround malaria transmission. Am J Trop Med Hyg 68: 16-22.
28. Lindblade KA, Eisele TP, Gimnig JE, Alaii JA, Odhiambo F, et al. (2004) Sustainability of reductions in malaria transmission and infant mortality in western Kenya with use of insecticide-treated bednets: 4 to 6 years of follow-up. Jama 291: 2571-2580.
29. Central BoSK, Health KMo, Macro O (2004) Kenya Demographic and Health Survey 2003.: Calverton, Maryland: CBS, MOH and ORC Macro.
30. Thwing JI, Odero CO, Odhiambo FO, Otieno KO, Kariuki S, et al. (2009) Invivo efficacy of amodiaquine-artesunate in children with uncomplicated Plasmodium falciparum malaria in western Kenya. Trop Med Int Health 14: 294-300.
31. Alloueche A, Bailey W, Barton S, Bwika J, Chimpeni P, et al. (2004) Comparison of chlorproguanil-dapsone with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in young African children: double-blind randomised controlled trial. Lancet 363: 1843-1848.
32. Kenya MoH (2006) National Guidelines for Diagnosis, Treatment and Prevention of Malaria for health workers in Kenya.: Division of Malaria Control, Ministry of Health.
33. Winstanley P, Watkins W, Muhia D, Szwandt S, Amukoye E, et al. (1997) Chlorproguanil/dapsone for uncomplicated Plasmodium falciparum malaria in young children: pharmacokinetics and therapeutic range. Trans R Soc Trop Med Hyg 91: 322-327.
34. Watkins WM, Brandling-Bennett AD, Nevill CG, Carter JY, Boriga DA, et al. (1988) Chlorproguanil/dapsone for the treatment of non-severe Plasmodium falciparum malaria in Kenya: a pilot study. Trans R Soc Trop Med Hyg 82: 398-403.
35. Sulo J, Chimpeni P, Hatcher J, Kublin JG, Plowe CV, et al. (2002) Chlorproguanil-dapsone versus sulfadoxine-pyrimethamine for sequential episodes of uncomplicated falciparum malaria in Kenya and Malawi: a randomized clinical trial. Lancet 360: 1136-1143.
36. 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.
37. Hietala SF, Bhattarai A, Msellem M, Röshammar D, Ali AS, et al. (2007) Population pharmacokinetics of amodiaquine and desethylamodiaquine in pediatric patients with uncomplicated falciparum malaria. J Pharmacokinet Pharmacodyn 34: 669-686.
38. Barnes KI, Little F, Smith PJ, Evans A, Watkins WM, et al. (2006) Sulfadoxinepyrimethamine pharmacokinetics in malaria: Pediatric dosing implications[ast]. Clin Pharmacol Ther 80: 582-596.
39. 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: 1365-1372.
40. Gupta S, Thapar MM, Mariga ST, Wernsdorfer WH, Bjorkman A (2002) Plasmodium falciparum: in vitro interactions of artemisinin with amodiaquine, pyronaridine, and chloroquine. Exp Parasitol 100: 28-35.
41. Doherty JF, Sadiq AD, Bayo L, Alloueche A, Olliaro P, et al. (1999) A randomized safety and tolerability trial of artesunate plus sulfadoxine- pyrimethamine versus sulfadoxine-pyrimethamine alone for the treatment of uncomplicated malaria in Gambian children. Trans R Soc Trop Med Hyg 93: 543-546.
42. von Seidlein L, Milligan P, Pinder M, Bojang K, Anyalebechi C, et al. (2000) Efficacy of artesunate plus pyrimethamine-sulphadoxine for uncomplicated malaria in Gambian children: a double-blind, randomised, controlled trial. Lancet 355: 352-357.
43. Targett G, Drakeley C, Jawara M, von Seidlein L, Coleman R, et al. (2001) Artesunate reduces but does not prevent posttreatment transmission of Plasmodium falciparum to Anopheles gambiae. J Infect Dis 183: 1254-1259.
44. Cisse B, Sokhna C, Boulanger D, Milet J, Bael H, et al. (2006) Seasonal intermittent preventive treatment with artesunate and sulfadoxine-pyrimethamine for prevention of malaria in Senegalese children: a randomised, placebocontrolled, double-blind trial. Lancet 367: 659-667.
45. Beutler E, Kuhl W, Vives-Corrons JL, Prchal JT (1989) Molecular heterogeneity of glucose-6-phosphate dehydrogenase A. Blood 74: 2550-2555.
46. Bloland PB, Boriga DA, Ruebush TK, McCormick JB, Roberts JM, et al. (1999) Longitudinal cohort study of the epidemiology of malaria infections in an area of intense malaria transmission II. Descriptive epidemiology of malaria infection and disease among children. Am J Trop Med Hyg 60: 641-648.
47. Cox DR (Series B 1972) Regression models and life tables (with discussion). Journal of the Royal Statistical Society 34: 187-220.
48. Liang KY, Zeger SL (1986) Longitudinal data analysis using generalized linear models. Biometrics 73: 13-22.
49. Clayton D, Hills M (1993) Statistical Models in Epidemiology. Oxford: Oxford University Press.
50. CDC (2005) A SAS Program for the CDC Growth Charts. National Center for Chronic Disease Prevention and Health Promotion.
51. Tagbor H, Bruce J, Browne E, Randal A, Greenwood B, 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: 1349-1356.
52. D'Alessandro U, ter Kuile FO (2006) Amodiaquine, malaria, pregnancy: the old new drug. Lancet 368: 1306-1307.
53. Fanello CI, Karema C, van Doren W, Rwagacondo CE, D'Alessandro U (2006) Tolerability of amodiaquine and sulphadoxine-pyrimethamine, alone or in combination for the treatment of uncomplicated Plasmodium falciparum malaria in Rwandan adults. Trop Med Int Health 11: 589-596.
54. Rwagacondo CE, Karema C, Mugisha V, Erhart A, Dujardin JC, et al. (2004) Is amodiaquine failing in Rwanda? Efficacy of amodiaquine alone and combined with artesunate in children with uncomplicated malaria. Trop Med Int Health 9: 1091-1098.
55. Gosling RD, Ghani AC, Deen JL, von Seidlein L, Greenwood BM, et al. (2008) Can changes in malaria transmission intensity explain prolonged protection and contribute to high protective efficacy of intermittent preventive treatment for malaria in infants? Malar J 7: 54.
56. Menendez C, Schellenberg D, Macete E, Aide P, Kahigwa E, et al. (2007) Varying efficacy of intermittent preventive treatment for malaria in infants in two similar trials: public health implications. Malar J 6: 132.
57. ter Kuile FO, Terlouw DJ, Kariuki SK, Phillips-Howard PA, Mirel LB, et al. (2003) Impact of permethrin-treated bed nets on malaria, anemia, and growth in infants in an area of intense perennial malaria transmission in western Kenya. Am J Trop Med Hyg 68: 68-77.
58. Nosten F, White NJ (2007) Artemisinin-based combination treatment of falciparum malaria. Am J Trop Med Hyg 77: 181-192.
59. Aponte JJ, Schellenberg D, Egan A, Breckenridge A, Carneiro I, et al. (2009) Efficacy and safety of intermittent preventive treatment with ulfadoxinepyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet 374: 1533-1542.