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01.12.2012 | Research | Ausgabe 1/2012 Open Access

Malaria Journal 1/2012

Efficacy of fixed-dose combination artesunate-amodiaquine versus artemether-lumefantrine for uncomplicated childhood Plasmodium falciparum malaria in Democratic Republic of Congo: a randomized non-inferiority trial

Zeitschrift:
Malaria Journal > Ausgabe 1/2012
Autoren:
Emmanuelle Espié, Angeles Lima, Benjamin Atua, Mehul Dhorda, Laurence Flévaud, Eric M Sompwe, Pedro Pablo Palma Urrutia, Philippe J Guerin
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1475-2875-11-174) contains supplementary material, which is available to authorized users.

Competing interests

The authors declare that they have no competing interests.

Authors’ contributions

The authors accept full responsibility for the overall content of this report. EE was the principal investigator of the study. She designed and coordinated the study, managed and analysed the data, and wrote the manuscript. AL participated to the development of the study protocol, gave a technical support to the investigator and revised the manuscript. BA, as director of the National Malaria Control Programme in DRC, gave support and approval of the study and revised the manuscript. LF participated in the development of the study protocol, gave a technical support for the laboratory issues, coordinated the external quality control of the reading of malaria slides and revised the manuscript. EMS, as the local authority and health staff, gave support and approval of the study and revised the manuscript. MD performed the PCR analyses and gave advice on PCR results interpretation. PPPU participated in the development of the study protocol, gave technical support to the investigators and revised the manuscript. JPG gave technical support to the principal investigator during the protocol writing, analysis and writing of the manuscript.

Abstract

Background

In 2005, the Democratic Republic of Congo (DRC) adopted artesunate and amodiaquine (ASAQ) as first-line anti-malarial treatment. In order to compare the efficacy of the fixed-dose formulation ASAQ versus artemether-lumefantrine (AL), a randomized, non-inferiority open-label trial was conducted in Katanga.

Methods

Children aged six and 59 months with uncomplicated Plasmodium falciparum malaria were enrolled and randomly allocated into one of the two regimens. The risk of recurrent parasitaemia by day 42, both unadjusted and adjusted by PCR genotyping to distinguish recrudescence from new infection, was analysed.

Results

Between April 2008 and March 2009, 301 children were included: 156 with ASAQ and 145 with AL. No early treatment failures were reported. Among the 256 patients followed-up at day 42, 32 patients developed late clinical or parasitological failure (9.9% (13/131) in the ASAQ group and 15.2% (19/125) in the AL group). After PCR correction, cure rates were 98.3% (95%CI, 94.1-99.8) in the ASAQ group and 99.1% (95%CI, 94.9-99.9) in the AL group (difference −0.7%, one sided 95% CI −3.1). Kaplan-Meier PCR-adjusted cure rates were similar. Both treatment regimens were generally well tolerated.

Conclusion

Both ASAQ and AL are highly effective and currently adequate as the first-line treatment of uncomplicated falciparum malaria in this area of Katanga, DRC. However, in a very large country, such as DRC, and because of possible emergence of resistance from other endemic regions, surveillance of efficacy of artemisinin-based combination treatments, including other evaluations of the resistance of ASAQ, need to be done in other provinces.

Trial registration

The protocol was registered with the clinicaltrials.gov, open clinical trial registry under the identifier number NCT01567423.
Zusatzmaterial
Authors’ original file for figure 1
12936_2012_2132_MOESM1_ESM.pdf
Authors’ original file for figure 2
12936_2012_2132_MOESM2_ESM.pdf
Authors’ original file for figure 3
12936_2012_2132_MOESM3_ESM.pdf
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