Research

Evaluation of the efficacy and safety of artemether-lumefantrine in the treatment of acute uncomplicated Plasmodium falciparum malaria in Nigerian infants and children

Catherine O Falade^1,2 , Oluwatoyin O Ogunkunle³ , Hannah O Dada-Adegbola⁴ , Adegoke G Falade³ , Patricia Ibarra de Palacios⁵ , Philip Hunt⁶ , Mailis Virtanen⁵ , Ayoade M Oduola² and Lateef A Salako¹

¹  Department of Pharmacology and Therapeutics, University of Ibadan, Nigeria

²  Institute for Advanced Medical Research and Training, College of Medicine, University College Hospital, Ibadan, Nigeria

³  Department of Pediatrics, University College Hospital, Ibadan, Nigeria

⁴  Department of Medical Microbiology, University College Hospital, Ibadan, Nigeria

⁵  Novartis Pharma AG, Basel, Switzerland

⁶  Novartis Horsham Research Centre, Horsham, UK

author email corresponding author email

Malaria Journal 2008, 7:246doi:10.1186/1475-2875-7-246

Published:	27 November 2008

Abstract

Background

The six-dose regimen of artemether-lumefantrine (AL) is now considered the gold standard for the treatment of uncomplicated Plasmodium falciparum malaria. There are few reports evaluating co-artemether in very young Nigerian infants and children. Results of the evaluation of the six-dose regimen in very young infants and children in Nigeria are presented in this report.

Methods

As part of a larger African study, this open label, non-comparative trial, assessed the efficacy and safety of six-dose regimen of AL tablets in 103 Nigerian infants and children weighing between five and 25 kg suffering from acute uncomplicated malaria. Treatment was administered under supervision over three days with children as in-patients. 12-lead ECG tracings were taken pre-treatment and at day 3.

Results

Ninety-three infants and children completed the study as stipulated by the protocol. Mean fever and parasite clearance times for the intent to treat population (ITT) were 24.9 h ± (1.28) and 26 h ± (4.14) and the corresponding figures for the per-protocol population (PP) were 19.24 h ± 13.9 and 25.62 h ± 11.25 respectively. Day 14 cure rates for the ITT and PP were 95.1% and 100% respectively while day 28 cure rates were 91.3% and 95.7% respectively. The overall PCR corrected day 28 cure rate was 95.1% for the ITT. The six-dose regimen of AL was well tolerated with no drug-related serious adverse events. Although six patients recorded a QTc prolongation of > 60 ms on D3 over D0 recording, no patient recorded a QTc interval > 500 ms.

Conclusion

The six-dose regimen of AL tablets is safe and effective for the treatment of acute uncomplicated malaria in Nigerian infants and children weighing between five and 25 kg.

Trial registration

NCT00709969