Intermittent preventive therapy for malaria with monthly artemether-lumefantrine for the post-discharge management of severe anaemia in children aged 4-59 months in southern Malawi: A multicentre, randomised, placebo-controlled trial

The Lancet Infectious Diseases

Volumn 12, Issue 3, 2012, Pages 191-200

  Phiri, Kamija ^a   Esan, Michael ^a,b   Van Hensbroek, Michael Boele ^b   Khairallah, Carole ^c   Faragher, Brian ^c   Ter Kuile, Feiko O ^b,c  

^a UNIVERSITY OF MALAWI   (Malawi)

^b UNIVERSITY OF AMSTERDAM   (Netherlands)

^c LIVERPOOL SCHOOL OF TROPICAL MEDICINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTEMETHER PLUS BENFLUMETOL; COTRIMOXAZOLE; PLACEBO; PYRIMETHAMINE PLUS SULFADOXINE; QUININE;

ANEMIA; ARTICLE; BLOOD TRANSFUSION; CHILD; CHILDHOOD MORTALITY; CONTROLLED STUDY; DISEASE SEVERITY; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG INTERMITTENT THERAPY; DRUG SAFETY; FEMALE; HOSPITAL DISCHARGE; HOSPITAL READMISSION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTED PATIENT; INFANT; INTERMITTENT PREVENTIVE THERAPY; MAJOR CLINICAL STUDY; MALARIA; MALAWI; MALE; MULTICENTER STUDY; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RISK REDUCTION; TREATMENT DURATION;

ANEMIA; ANTIMALARIALS; ARTEMISININS; CHILD, PRESCHOOL; DOUBLE-BLIND METHOD; DRUG COMBINATIONS; ETHANOLAMINES; FEMALE; FLUORENES; HUMANS; INFANT; MALARIA; MALAWI; MALE;

EID: 84857193453     PISSN: 14733099     EISSN: 14744457     Source Type: Journal    
DOI: 10.1016/S1473-3099(11)70320-6     Document Type: Article

References (37)

1. Phiri KS, Calis JC, Faragher B, et al. Long term outcome of severe anaemia in Malawian children. PLoS One 2008, 3:e2903.
2. Lackritz EM, Campbell CC, Ruebush TK, et al. Effect of blood transfusion on survival among children in a Kenyan hospital. Lancet 1992, 340:524-528.
3. Marsh K, Forster D, Waruiru C, et al. Indicators of life-threatening malaria in African children. N Engl J Med 1995, 332:1399-1404.
4. Biemba G, Dolmans D, Thuma PE, Weiss G, Gordeuk VR Severe anaemia in Zambian children with Plasmodium falciparum malaria. Trop Med Int Health 2000, 5:9-16.
5. Calis JC, Phiri KS, Faragher EB, et al. Severe anemia in Malawian children. N Engl J Med 2008, 358:888-899.
6. Zucker JR, Lackritz EM, Ruebush TK, et al. Childhood mortality during and after hospitalization in western Kenya: effect of malaria treatment regimens. Am J Trop Med Hyg 1996, 55:655-660.
7. Price RN, Simpson JA, Nosten F, et al. Factors contributing to anemia after uncomplicated falciparum malaria. Am J Trop Med Hyg 2001, 65:614-622.
8. Bloland PB, Lackritz EM, Kazembe PN, Were JB, Steketee R, Campbell CC Beyond chloroquine: implications of drug resistance for evaluating malaria therapy efficacy and treatment policy in Africa. J Infect Dis 1993, 167:932-937.
9. Looareesuwan S, Merry AH, Phillips RE, et al. Reduced erythrocyte survival following clearance of malarial parasitaemia in Thai patients. Br J Haematol 1987, 67:473-478.
10. Sinclair D, Zani B, Donegan S, Olliaro P, Garner P Artemisinin-based combination therapy for treating uncomplicated malaria. Cochrane Database Syst Rev 2009, 3. CD007483.
11. White NJ Intermittent presumptive treatment for malaria. PLoS Med 2005, 2:e3.
12. ter Kuile FO, van Eijk AM, Filler SJ Effect of sulfadoxine-pyrimethamine resistance on the efficacy of intermittent preventive therapy for malaria control during pregnancy: a systematic review. JAMA 2007, 297:2603-2616.
13. Aponte JJ, Schellenberg D, Egan A, et al. Efficacy and safety of intermittent preventive treatment with sulfadoxine-pyrimethamine for malaria in African infants: a pooled analysis of six randomised, placebo-controlled trials. Lancet 2009, 374:1533-1542.
14. Wilson AL A systematic review and meta-analysis of the efficacy and safety of intermittent preventive treatment of malaria in children (IPTc). PLoS One 2011, 6:e16976.
15. Bojang KA, Milligan PJ, Conway DJ, et al. Prevention of the recurrence of anaemia in Gambian children following discharge from hospital. PLoS One 2010, 5:e11227.
16. Ferreira-Gonzalez I, Permanyer-Miralda G, Busse JW, et al. Methodologic discussions for using and interpreting composite endpoints are limited, but still identify major concerns. J Clin Epidemiol 2007, 60:651-657.
17. ter Kuile FO, Steketee RW Intermittent preventive treatment in infants-adjusting expectations and seeing opportunity. J Infect Dis 2006, 194:269-272.
18. Cheung YB, Xu Y, Tan SH, Cutts F, Milligan P Estimation of intervention effects using first or multiple episodes in clinical trials: the Andersen-Gill model re-examined. Stat Med 2010, 29:328-336.
19. Cairns M, Gosling R, Carneiro I, et al. Duration of protection against clinical malaria provided by three regimens of intermittent preventive treatment in Tanzanian infants. PLoS One 2010, 5:e9467.
20. Calis JC, Phiri KS, Vet RJ, et al. Erythropoiesis in HIV-infected and uninfected Malawian children with severe anemia. Aids 2010, 24:2883-2887.
21. Boele van Hensbroek M, Calis JC, Phiri KS, et al. Pathophysiological mechanisms of severe anaemia in Malawian children. PLoS One 2010, 5:e12589.
22. Mermin J, Ekwaru JP, Liechty CA, et al. Effect of co-trimoxazole prophylaxis, antiretroviral therapy, and insecticide-treated bednets on the frequency of malaria in HIV-1-infected adults in Uganda: a prospective cohort study. Lancet 2006, 367:1256-1261.
23. Malamba S, Sandison T, Lule J, et al. Plasmodium falciparum dihydrofolate reductase and dihyropteroate synthase mutations and the use of trimethoprim-sulfamethoxazole prophylaxis among persons infected with human immunodeficiency virus. Am J Trop Med Hyg 2010, 82:766-771.
24. Naidoo I, Roper C Drug resistance maps to guide intermittent preventive treatment of malaria in African infants. Parasitology 2011, 138:1469-1479.
25. Zongo I, Dorsey G, Rouamba N, et al. Randomized comparison of amodiaquine plus sulfadoxine-pyrimethamine, artemether-lumefantrine, and dihydroartemisinin-piperaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Burkina Faso. Clin Infect Dis 2007, 45:1453-1461.
26. Zongo I, Dorsey G, Rouamba N, et al. Artemether-lumefantrine versus amodiaquine plus sulfadoxine-pyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised non-inferiority trial. Lancet 2007, 369:491-498.
27. Gosling RD, Gesase S, Mosha JF, et al. Protective efficacy and safety of three antimalarial regimens for intermittent preventive treatment for malaria in infants: a randomised, double-blind, placebo-controlled trial. Lancet 2009, 374:1521-1532.
28. Slutsker LM, Khoromana CO, Payne D, et al. Mefloquine therapy for Plasmodium falciparum malaria in children under 5 years of age in Malawi: in vivo/in vitro efficacy and correlation of drug concentration with parasitological outcome. Bull World Health Organ 1990, 68:53-59.
29. Cisse B, Cairns M, Faye E, et al. Randomized trial of piperaquine with sulfadoxine-pyrimethamine or dihydroartemisinin for malaria intermittent preventive treatment in children. PLoS One 2009, 4:e7164.
30. Bojang K, Akor F, Bittaye O, et al. A randomised trial to compare the safety, tolerability and efficacy of three drug combinations for intermittent preventive treatment in children. PLoS One 2010, 5:e11225.
31. Bojang KA, Palmer A, Boele van Hensbroek M, Banya WA, Greenwood BM Management of severe malarial anaemia in Gambian children. Trans R Soc Trop Med Hyg 1997, 91:557-561.
32. Desai MR, Mei JV, Kariuki SK, et al. Randomized, controlled trial of daily iron supplementation and intermittent sulfadoxine-pyrimethamine for the treatment of mild childhood anemia in western Kenya. J Infect Dis 2003, 187:658-666.
33. Tomashek KM, Woodruff BA, Gotway CA, Bloland P, Mbaruku G Randomized intervention study comparing several regimens for the treatment of moderate anemia among refugee children in Kigoma Region, Tanzania. Am J Trop Med Hyg 2001, 64:164-171.
34. Verhoef H, West CE, Nzyuko SM, et al. Intermittent administration of iron and sulfadoxine-pyrimethamine to control anaemia in Kenyan children: a randomised controlled trial. Lancet 2002, 360:908-914.
35. Hochman M, McCormick D Endpoint selection and relative (versus absolute) risk reporting in published medication trials. J Gen Intern Med 2011, 26:1246-1252.
36. Kweku M, Webster J, Adjuik M, Abudey S, Greenwood B, Chandramohan D Options for the delivery of intermittent preventive treatment for malaria to children: a community randomised trial. PLoS One 2009, 4:e7256.
37. Bojang KA, Akor F, Conteh L, et al. Two strategies for the delivery of IPTc in an area of seasonal malaria transmission in the Gambia: a randomised controlled trial. PLoS Med 2011, 8:e1000409.