Skip to main content

Advertisement

SpringerLink
Log in

Descriptive study on the efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Sudan

  • Clinical Trial
  • Published:
European Journal of Clinical Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

The aim of this study was to investigate the efficacy of artemether-lumefantrine in treating uncomplicated Plasmodium falciparum malaria in four sentinel areas in Sudan with different malaria transmission (Damazin, Sinnar, and Kosti in the north, and Juba in the south).

Methods

World Health Organization protocol for assessing antimalarial drug efficacy in treating uncomplicated P. falciparum malaria was employed. A total of 2,139 patients were screened, and 771 had P. falciparum monoinfection. Only 291 met the enrollment criteria and gave written consent to be recruited in the study. Patients were treated with artemether-lumefantrine tablets in a six-dose regimen calculated according to body weight. Tablets were given at 0, 8, 24, 36, 48, and 60 h. Patients were followed up for 28 days.

Results

A total of 291 patients were recruited to the study, of whom ten [3.4; 95% confidence interval (CI):1.8–6.4%] patients showed early treatment failure (ETF) or late clinical failure (LCF) and were excluded from further follow-up. Of the remaining 281 patients, 276 (98.2%; 95% CI: 95.7–99.3%) completed the 28-day follow-up. Of these, 274 (99.3%; 95% CI: 97.1–99.9%) had adequate clinical and parasitological response (ACPR), and two (0.7%; 95% CI: 0.13–2.9%) showed late parasitological failure (LPF) at days 21 and 28. The overall mean ± standard deviation (SD) of parasitemia and fever clearance times were 36.4 (23.7) h and 34.6 (19.2) h, respectively. Mild and reversible adverse effects were reported by 11 patients (3.8%; CI: 2.0–7.0%) and were relieved without the need for termination of drug therapy or supportive treatment.

Conclusions

Our findings showed that artemether-lumefantrine was an effective and safe drug for treating uncomplicated P. falciparum malaria in northern and southern Sudan.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

Similar content being viewed by others

References

  1. Olliaro PL, Taylor WRJ (2003) Review article antimalarial compound from bench to bedside. J Exp Biol 206:35753–35759

    Article  Google Scholar 

  2. Gilles HM (1991) Introduction. In: WHO (ed) A practical handbook in the management of severe and complicated malaria, 2nd edn. World health Organization, Geneva, pp 1–4

    Google Scholar 

  3. Malik EM, Khalfalla OM (2004) Malaria in Sudan: past, present and the future. Gezira Journal of Health Sciences I(Suppl):47–51

    Google Scholar 

  4. White NJ, Nosten F, Looareesuwan S et al (1999) Averting a malaria disaster. Lancet 353:1965–67

    Article  CAS  PubMed  Google Scholar 

  5. Zucker JR, Ruebush TK, Obonyo C, Otieno J, Campell CC (2003) The mortality consequences of the continued use of chloroquine in Africa: experience in Siaya, westwern Kenya. Am J Trop Med Hyg 68:386–390

    CAS  PubMed  Google Scholar 

  6. Babiker HA, Pringle SJ, Abdel-Muhsin A, Mackinnon M, Hunt P, Walliker D (2001) High-level chloroquine resistance in Sudanese isolates of Plasmodium falciparum is associated with mutations in the chloroquine resistance transporter gene pfcrt and the multidrug resistance Gene pfmdr1. J Infect Dis 183(10):1535–1538

    Article  CAS  PubMed  Google Scholar 

  7. Adam I, Osman ME, ElGhazali G, Ahmed GI, Gustafson LL, Elbashir MI (2204) Efficacies of chloroquine, sulphadoxine-pyrimethamine and quinine for the treatment of uncomplicated Plasmodium falciparum malaria in Eastern Sudan. Ann Trop Med Parasitol 98(7):661–666

    Article  Google Scholar 

  8. Salah MT, Mohammed MM, Himeidan YE, Malik EM, Elbashir MI, Adam I (2005) A randomized comparison of sulphadoxine-pyrimethamine and combination of sulphadoxine pyrimethamine with chloroquine in the treatment of uncomplicated falciparum malaria in Eastern Sudan. Saudi Med J 26(1):147–148

    PubMed  Google Scholar 

  9. Malik EM, Nour SM, Hamid IK, Elmardi KA, Mohamed TA, Ahmed ES (2005) From home to hospital: Beliefs and practices related to severe malaria in Sudan. J Fam Community Med 12:85–90

    Google Scholar 

  10. Ibrahim AM, Ali FR, Ali ME (1992) Assessment of chloroquine resistance of Plasmodium falciparum in children of Wad Medani (Central Sudan). J Trop Pediat 38:162–166

    CAS  Google Scholar 

  11. Adam I, Ibrahim MH, A/elbasit IA, Elbashir MI (2004) Efficacy of sulfadoxine- pyrimethamine for uncomplicated Plasmodium falciparum malaria in a small sample of Sudanese children. East Mediterr Health J 10:309–314

    CAS  PubMed  Google Scholar 

  12. van den Broek IV, Gatkoi T, Lowoko B, Nzila A, Ochong E, Keus K (2003) Chloroquine, sulfadoxine-pyrimethamine and amodiaquine efficacy for the treatment of uncomplicated Plasmodium falciparum malaria in Upper Nile, south Sudan. Trans R Soc Trop Med Hyg 97(2):229–235

    Article  PubMed  Google Scholar 

  13. Guerin PJ, Olliaro P, Nosten F et al (2002) Malaria: current status of control, diagnosis, treatment, and a proposed agenda for research and development. Lancet Infect Dis 2:564–573

    Article  PubMed  Google Scholar 

  14. Greenwood BM, Bojang K, Whitty CJ, Targett GA (2005) Malaria. Lancet 365:1487–1498

    Article  CAS  PubMed  Google Scholar 

  15. World Health Organization (2006) Global Antimalarial Drug Policies database-AFRO. Antimalarial treatment policies for P. falciparum and P. vivax by country in WHO Africa region. Available Via DIALOG. http://www.who.int/malaria/amdp/amdp_afro.htm. Accessed 16 May 2009

  16. International Artemisinin Study Group (2004) Artesunate combinations for treatment of malaria: meta-analysis. Lancet 363:9–17

    Article  Google Scholar 

  17. Malik EM, Mohamed TA, Elmardi KA, Mowien RM, Elhassan AH, Elamin SB, Mannan AA, Ahmed ES (2006) From chloroquine to artemisinin-based combination therapy: the Sudanese experience. Malar J 5:65

    Article  CAS  PubMed  Google Scholar 

  18. Adam I, A-Elbasit IE, Idris SM, Malik EM, Elbashir MI (2005) A comparison of the efficacy of artesunate plus sulfadoxine-pyrimethamine with that of sulfadoxine-pyrimethamine alone, in the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan. Ann Trop Med Parasitol 9:449–455

    Article  Google Scholar 

  19. Hamour S, Melaku Y, Keus K, Wambugu J, Atkin S, Montgomery J, Ford N, Hook C, Checchi F (2005) Malaria in the Nuba Mountains of Sudan: baseline genotypic resistance and efficacy of the artesunate plus sulfadoxine-pyrimethamine and artesunate plus amodiaquine combinations. Trans R Soc Trop Med Hyg 99:548–554

    Article  CAS  PubMed  Google Scholar 

  20. van den Broek I, Amsalu R, Balasegaram M, Hepple P, Alemu E, Hussein el B, Al-Faith M, Montgomery J, Checchi F (2005) Efficacy of two artemisinin combination therapies for uncomplicated falciparum malaria in children under 5 years, Malakal, Upper Nile, Sudan. Malar J 4:14

    Article  PubMed  Google Scholar 

  21. Elamin SB, Malik EM, Abdelgadir T, Khamiss AH, Mohammed MM, Ahmed ES, Adam I (2005) Artesunate plus sulfadoxine-pyrimethamine for treatment of uncomplicated Plasmodium falciparum malaria in Sudan. Malar J 4:41

    Article  PubMed  Google Scholar 

  22. Mohamed AO, Eltaib EH, Ahmed OA, Elamin SB, Malik EM (2006) The efficacies of artesunate-sulfadoxine-pyrimethamine and artemether-lumefantrine in the treatment of uncomplicated, Plasmodium falciparum malaria, in an area of low transmission in central Sudan. Ann Trop Med Parasitol 100:5–10

    Article  CAS  PubMed  Google Scholar 

  23. Adam I, A-Elbasit IE, Elbashir MI (2005) Efficacies of mefloquine alone and of artesunate followed by mefloquine, for the treatment of uncomplicated, Plasmodium falciparum malaria in eastern Sudan. Ann Trop Med Parasitol 99:111–117

    Article  CAS  PubMed  Google Scholar 

  24. Salah MT, Faroug M, Magzoub MM, Adam I (2006) Efficacy of artemether-lumefantrine (Co-Artesiane®) suspension in the treatment of uncomplicated Plasmodium falciparum malaria among children under 5 years in eastern Sudan. Trop J Pharm Res 5(1):551–555

    Google Scholar 

  25. Mukhtar EA, Gadalla NB, El-zaki S-EG, Mukhtar I, Mansour FA, Babiker A, El-Sayed BB (2007) A comparative study on the efficacy of artesunate plus sulphadoxine/pyrimethamine versus artemether-lumefantrine in eastern Sudan. Malar J 6:92

    Article  PubMed  Google Scholar 

  26. World Health Organization (2003) Assessment and monitoring of antimalarial drug efficacy for the treatment of uncomplicated falciparum malaria. http://apps.who.int/malaria/docs/ProtocolWHO.pdf

  27. Falade C, Makanga M, Premji Z, Ortmann CE, Stockmeyer M, de Palacios PI (2005) Efficacy and safety of artemether-lumefantrine (Coartem) tablets (six-dose regimen) in African infants and children with acute, uncomplicated falciparum malaria. Trans R Soc Trop Med Hyg 99:459–467

    Article  CAS  PubMed  Google Scholar 

  28. Koram KA, Abuaku B, Duah N, Quashie N (2005) Comparative efficacy of antimalarial drugs including ACTs in the treatment of uncomplicated malaria among children under 5 years in Ghana. Acta Tropica 95:194–203

    Article  CAS  PubMed  Google Scholar 

  29. Jima D, Tesfaye G, Medhin A, Kebede A, Argaw D, Babaniyi O (2005) Safety and efficacy of artemether-lumefantrine in the treatment of uncomplicated falciparum malaria in Ethiopia. East Afr Med J 82:387–390

    CAS  PubMed  Google Scholar 

  30. Mutabingwa TK (2005) Artemisinin-based combination therapies (ACTs): best hope for malaria treatment but inaccessible to the needy! Acta Trop 95:305–315

    Article  CAS  PubMed  Google Scholar 

  31. Agnamey P, Brasseur P, Cisse M, Gaye O, Dumoulin J, Rigal J, Taylor WR, Olliaro P (2005) Economic evaluation of a policy change from single-agent treatment for suspected malaria to artesunate-amodiaquine for microscopically confirmed uncomplicated falciparum malaria in the Oussouye District of south-western Senegal. Trop Med Int Health 10:926–933

    Article  CAS  PubMed  Google Scholar 

  32. Bjorkman A, Bhattarai A (2005) Public health impact of drug resistant Plasmodium falciparum malaria. Acta Trop 94:163–169

    PubMed  Google Scholar 

  33. Trape JF (2001) The public health impact of chloroquine resistance in Africa. Am J Trop Med Hyg 64:12–17

    CAS  PubMed  Google Scholar 

  34. Muheki C, McIntyre D, Barnes KI (2004) Artemisinin-based combination therapy reduces expenditure on malaria treatment in KwaZulu Natal, South Africa. Trop Med Int Health 9:959–966

    Article  CAS  PubMed  Google Scholar 

  35. Abdu Z, Mohammed Z, Bashier I, Eriksson B (2004) The impact of user fee exemption on service utilization and treatment seeking behaviour: the case of malaria in Sudan. Int J Health Plann Manage 19:S95–106

    Article  PubMed  Google Scholar 

  36. Whitty CJM, Allan R, Wiseman V, Ochola S et al (2004) Averting a malaria disaster in Africa-where does the buck stop? Bull World Health Organ 82:381–384

    PubMed  Google Scholar 

  37. World Health Organization (2003) Access to antimalarial medicines: Improving the affordability and financing of artemisinin-based combination therapies. http://apps.who.int/malaria/cmc_upload/0/000/016/745/37268_ACT_final2.pdf

  38. Awad AI, Eltayeb IB (2007) Self-medication practices with antibiotics and antimalarials among Sudanese undergraduate university students. Ann Pharmacother 41(7):1249–1255

    Article  PubMed  Google Scholar 

  39. Awad AI, Eltayeb IB, Capps PAG (2006) Self-medication practices in Khartoum State, Sudan. Eur J Clin Pharmacol 62(4):317–24

    Article  PubMed  Google Scholar 

  40. Awad AI, Eltayeb IB, Matowe L, Thalib L (2005) Self-medication with antibiotics and antimalarials in the community of Khartoum State, Sudan. J Pharm Pharmaceut Sci 8(2):326–331

    Google Scholar 

Download references

Acknowledgements

This study was supported financially by the World Health Organization. The authors thank the medical staff in the four sites for their assistance and collaboration in carrying out the study, and all patients for their cooperation. The study complies with the current laws of Sudan.

Author information

Authors and Affiliations

  1. National Malaria Control Programme, Federal Ministry of Health, P.O. Box 1204, Khartoum, Sudan

    Sakina Babikir Elamin, Khalid Abdelmutalab Elmardi, Asma Hashim Al Hassan, Elfatih Mohammad Malik & Tarig Abedelgadir Mohamad

  2. Department of Pharmacy Practice, Faculty of Pharmacy, Kuwait University, P.O. Box 24923, Safat, 13110, Kuwait

    Abdelmoneim Ismail Awad

  3. Department of Pharmacology, Faculty of Pharmacy, University of Khartoum, P.O. Box 1996, Khartoum, Sudan

    Idris Babiker Eltayeb

  4. Department of Biochemistry, Faculty of Medicine and Health Science, University of El Imam El Mahdi, P.O. Box 209, Kosti, Sudan

    AbedlRahim Osman Mohamed

Authors
  1. Sakina Babikir Elamin
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Abdelmoneim Ismail Awad
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Idris Babiker Eltayeb
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Khalid Abdelmutalab Elmardi
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Asma Hashim Al Hassan
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. AbedlRahim Osman Mohamed
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Elfatih Mohammad Malik
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Tarig Abedelgadir Mohamad
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Abdelmoneim Ismail Awad.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Elamin, S.B., Awad, A.I., Eltayeb, I.B. et al. Descriptive study on the efficacy of artemether-lumefantrine in the treatment of uncomplicated Plasmodium falciparum malaria in Sudan. Eur J Clin Pharmacol 66, 231–237 (2010). https://doi.org/10.1007/s00228-009-0750-4

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00228-009-0750-4

Keywords

Search

Navigation