Assessment of efficacy and safety of artesunate plus sulfadoxine pyrimethamine combination for treatment of uncomplicated falciparum malaria

Yash N. Goyal, Nishant B. Bhansali, Krunal C. Solanki, Rusva A. Mistry, Anil P. Singh

Abstract


Background: Resistance of Plasmodium falciparum to antimalarial drugs is common in India. World Health Organization (WHO) recommends artemisinin‑based combination therapy (ACT) to counter the development of resistance in P. falciparum. WHO recommends that ideally antimalarial drug treatment policy or guidelines should be reviewed regularly and updated at least once every 24 months. In consideration to the above recommendation, we planned to conduct the following study. The objective was to determine the efficacy and safety of artesunate + sulphadoxine‑pyrimethamine (AS + SP) in patients with uncomplicated P. falciparum malaria.

Methods: The study included 60 patients of uncomplicated P. falciparum. Each patient received AS + SP as per WHO guidelines. Diagnosis was confirmed by peripheral blood film. All patients were followed‑up on days 1, 3, 14, and 28 for detailed clinical and parasitological examination.

Results: Of a total 60 patients, 55 patients were followed‑up for 28 days. Remaining 5 patients were lost in follow‑up. As per protocol analysis, 91% (50) of patients had demonstrated adequate clinical and parasitological response. Remaining 9% (5) had treatment failure in which 5.5% (3) had late parasitological failure and 3.6% (2) had late clinical failure. In our study, mean parasite clearance time was 45.2 ± 4.2 hrs.

Conclusion: AS + SP is safe and effective drug for the treatment of uncomplicated falciparum malaria. However, the efficacy of this ACT needs to be carefully monitored periodically since treatment failure can occur due to resistance.


Keywords


Uncomplicated Plasmodium falciparum malaria, Artemisinin based combination therapy, Artesunate + sulfadoxine pyrimethamine

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References


National Vector Borne Disease Control Programme: Guidelines for the Diagnosis and Treatment of Malaria in India, 2010. Available from: http://www. mrcindia.org/guidelines_for_ Treatment of Malaria 2010 pdf. [Last accessed on 2010 Aug 20].

Sharma VP. Battling the malaria iceberg with chloroquine in India. Malar J. 2007;6:105.

World Health Organization. Guidelines for the Treatment of Malaria. 2nd Edition. Geneva: World Health Organization; 2010. Available from: http://www.wholibdoc.Who.Int/Publications/2010/9789241547925_eng.pdf. [Last accessed on 2010 Aug 15].

World Health Organization. Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria, 2003. Available from: http://www.whqlibdoc.who.int/hq/2003/WHO_HTM_RBM_2003.50.pdf. [Last accessed on 2010 Aug 22].

Guidelines for Diagnosis and Treatment of Malaria in India, 2010. Available from: http://www.nvbdcp.gov.in/Doc/Technical Guidelines Malaria 2010.pdf. [Last accessed on 2010 Jun 15].

WHO, 1972. International drug monitoring. Role of National Centres. WHO Technical Report Series No. 498. Geneva, Switzerland: 2012. Available from: http://www.who umc.org/graphics/24756.pdf. [Last accessed on 2010 Jul 15].

Safety Monitoring of Medicinal Products. Guidelines for Setting Up & Running a Pharmacovigilance Centre. Uppsala Monitoring Centre WHO Collaborating Centre for International Drug Monitoring. London: EQUUS; 2000. Available from: http://www.apps.who.int/medicinedocs/es/d/Jh2934e/. [Last accessed on 2010 Jul 15].

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49 (9):2229 32.

Schumock GT, Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27(6):538.

Dondorp MA, Nosten F, Poravuth YI, Das D, Phyo AP, Tarning J, et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009;361:455 67.

Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM, et al. Evidence of artemisinin resistant malaria in western Cambodia. N Engl J Med. 2008;359(24):2619 20.

Mockenhaupt FP, Ehrhardt S, Dzisi SY, Teun Bousema J, Wassilew N, Schreiber J, et al. A randomized, placebo controlled, double blind trial on sulfadoxine pyrimethamine alone or combined with artesunate or amodiaquine in uncomplicated malaria. Trop Med Int Health. 2005;10(6):512 20.

Seboxa T, Mao P, Pinchouk N, Anbessie J, Alemu H, Diro E. Artemether Lumefantrin (Coartem) and artesunate with sulfadoxine pyrimethamine therapeutic efficacy in the treatment of uncomplicated malaria at Gilgel Gibe II (GGII) South Western Ethiopia. Ethiop Med J. 2010;48(4):285 91.

Abacassamo F, Enosse S, Aponte JJ, G JJ, OlivA FX, QuintQ L, Mabunda S, et al. Efficacy of chloroquine, amodiaquine, sulphadoxine pyrimethamine and combination therapy with artesunate in Mozambican children with non complicated malaria. Trop Med Int Health. 2004;9(2):200 8.

Dorsey G, Njama D, Kamya MR, Cattamanchi A, Kyabayinze D, Staedke SG, et al. Sulfadoxine/pyrimethamine alone or with amodiaquine or artesunate for treatment of uncomplicated malaria: A longitudinal randomised trial. Lancet. 2002;360(9350):2031 8.

Mukhtar EA, Gadalla NB, El Zaki SE, Mukhtar I, Mansour FA, Babiker A, et al. A comparative study on the efficacy of artesunate plus sulphadoxine/pyrimethamine versus artemether lumefantrine in eastern Sudan. Malar J. 2007;6:92.

Bonnet M, Broek Iv, van Herp M, Urrutia PP, van Overmeir C, Kyomuhendo J, et al. Varying efficacy of artesunate+amodiaquine and artesunate +sulphadoxine pyrimethamine for the treatment of uncomplicated falciparum malaria in the Democratic Republic of Congo: A report of two in vivo studies. Malar J. 2009;8:192.

Ayede IA, Falade AG, Sowunmi A, Jansen FH. An open randomized clinical trial in comparing two artesunate based combination treatments on Plasmodium falciparum malaria in Nigerian children: Artesunate/sulphamethoxypyrazine/pyrimethamine (fixed dose over 24 hours) versus artesunate/amodiaquine (fixed dose over 48 hours). Malar J. 2010;9:378.

Valecha N, Srivastava P, Mohanty SS, Mittra P, Sharma SK, Tyagi PK, et al. Therapeutic efficacy of artemether-lumefantrine in uncomplicated falciparum malaria in India. Malar J. 2009;8:107.