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Randomized Controlled Trial
. 2020 Mar 10:35:68.
doi: 10.11604/pamj.2020.35.68.20849. eCollection 2020.

Efficacy of artemether-lumefantrine and artesunate-amodiaquine as first line therapy of uncomplicated malaria in Burkina Faso, 11 years after policy change

Affiliations
Randomized Controlled Trial

Efficacy of artemether-lumefantrine and artesunate-amodiaquine as first line therapy of uncomplicated malaria in Burkina Faso, 11 years after policy change

Issaka Zongo et al. Pan Afr Med J. .

Abstract

Introduction: Artemether-lumefantrine (AL) and artesunate-amodiaquine (ASAQ) are the first line therapy of uncomplicated malaria in Burkina Faso. We assessed the treatment efficacy, tolerability of these drugs 11 years following its adoption as first line treatment.

Methods: In this opened randomized controlled trial carried out in 2016, participants with age over 6 months who consented to participate were randomly assigned treatment with artemether-lumefantrine or artesunate-amodiaquine and followed up for 28 days. Primary endpoint was the treatment efficacy over 28 days of follow up unadjusted by Polymerase chain reaction (PCR).

Results: Two hundred and eighty-one (281) participants were enrolled and the completion rate was 92.9%. No early treatment failure was found. Adequate clinical and parasitological responses were significantly higher in artesunate-amodiaquine group (97% versus 85.2%, p = 0.0008). On day 28, the risk of failure was 4 times higher in AL group 20.14%, 95% CI (13-30.47) against 5.16%, 95% CI (1.91-13.54) in ASAQ group. All treatments had a similar and good tolerability profile.

Conclusion: Eleven years following artemether-lumefantrine and artesunate-amodiaquine adoption as first line therapy for uncomplicated malaria in Burkina Faso, artemether-lumefantrine retained fairly good efficacy even though its efficacy fell below WHO threshold of 90% considering uncorrected outcome.

Keywords: Burkina Faso; first line ACTs efficacy; malaria.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Trial profile: this figure shows the number of participants of the study at different time point starting from enrollment to the last day of follow up in each arm; overall, more than 90% of enrolled participants finished the study and have an assigned outcome
Figure 2
Figure 2
Kaplan Meier failure function: this figure shows the risk of treatment failure at each time point in the follow up and when participant left and were censored; the cumulative number of failures increased gradually in artmether-lumefantrine group while in the artesunate-amodiaquine group, the line remained on zero up to day 14
Figure 3
Figure 3
Fever clearance time: this figures shows the trend in fever relief following the initiation of the treatment in each arm; almost all patients were apyretic on day 2 and 3 for artemether-lumefantrine treated participants and very few remained on day 3

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