Research

Sulphadoxine/pyrimethamine versus amodiaquine for treating uncomplicated childhood malaria in Gabon: A randomized trial to guide national policy

Basile Nsimba¹ , Vincent Guiyedi² , Modeste Mabika-Mamfoumbi² , Jean Romain Mourou-Mbina² , Edgard Ngoungou² , Marielle Bouyou-Akotet² , Romaric Loembet² , Rémy Durand³ , Jacques Le Bras⁴ and Maryvonne Kombila²

¹  National Malaria Control Programme – Division for Disease Control, Ministry of Health, Brazzaville, Congo

²  Department of Parasitology-Mycology and Tropical Diseases, Faculty of Medicine and Health Sciences, Libreville, Gabon

³  Parasitology Laboratory, Avicenne Hospital, AP-HP, and EA 3406, Paris 13 University, Bobigny, France

⁴  National Malaria Reference Centre, Bichat-Claude Bernard Hospital, Paris, France, and EA 209, University Paris Descartes, France

author email corresponding author email

Malaria Journal 2008, 7:31doi:10.1186/1475-2875-7-31

Published:	12 February 2008

Abstract

Background

In Gabon, following the adoption of amodiaquine/artesunate combination (AQ/AS) as first-line treatment of malaria and of sulphadoxine/pyrimethamine (SP) for preventive intermittent treatment of pregnant women, a clinical trial of SP versus AQ was conducted in a sub-urban area. This is the first study carried out in Gabon following the WHO guidelines.

Methods

A random comparison of the efficacy of AQ (10 mg/kg/day × 3 d) and a single dose of SP (25 mg/kg of sulphadoxine/1.25 mg/kg of pyrimethamine) was performed in children under five years of age, with uncomplicated falciparum malaria, using the 28-day WHO therapeutic efficacy test. In addition, molecular genotyping was performed to distinguish recrudescence from reinfection and to determine the frequency of the dhps K540E mutation, as a molecular marker to predict SP-treatment failure.

Results

The day-28 PCR-adjusted treatment failures for SP and AQ were 11.6% (8/69; 95% IC: 5.5–22.1) and 28.2% (20/71; 95% CI: 17.7–38.7), respectively This indicated that SP was significantly superior to AQ (P = 0.019) in the treatment of uncomplicated childhood malaria and for preventing recurrent infections. Both treatments were safe and well-tolerated, with no serious adverse reactions recorded. The dhps K540E mutation was not found among the 76 parasite isolates tested.

Conclusion

The level of AQ-resistance observed in the present study may compromise efficacy and duration of use of the AQ/AS combination, the new first-line malaria treatment. Gabonese policy-makers need to plan country-wide and close surveillance of AQ/AS efficacy to determine whether, and for how long, these new recommendations for the treatment of uncomplicated malaria remain valid.