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Observational Study
. 2023 May 25;23(1):359.
doi: 10.1186/s12879-023-08260-6.

Use of artesunate in the treatment of severe imported malaria in France: review of the effectiveness and real-life safety in two French university hospitals

M Bonsergent  1 , M Tching-Sin  2 , S Honoré  3 , P Bertault-Peres  3 , A Lepelletier  2 , L Flet  2 , T Perez  3
Affiliations
Observational Study

Use of artesunate in the treatment of severe imported malaria in France: review of the effectiveness and real-life safety in two French university hospitals

M Bonsergent et al. BMC Infect Dis. .

Abstract

Background: Intravenous artesunate (AS) is the first-line treatment for patients with severe imported malaria (SIM) worldwide. However, after 10 years of use in France, AS hasn't yet received marketing authorization.The purpose of this study was to assess the real-life effectiveness and safety of AS in the treatment of SIM in two Hospitals in France.

Methods: We performed a bicenter retrospective and observational study. All patients treated with AS for SIM between 2014 and 2018 and 2016-2020 were included. The effectiveness of AS was evaluated by parasite clearance, number of deaths, and the length of hospital stay. The real-life safety was assessed by related adverse events (AE) and monitoring of biological blood parameters during the hospital stay and follow-up period.

Results: 110 patients were included during the six-year study period. 71.8% of patients were parasite-negative of their day 3 thick and thin blood smears after AS treatment. No patients discontinued AS due to an AE and no serious AE were declared. Two cases of delayed post-artesunate hemolysis occurred and required blood transfusions.

Conclusion: This study highlights effectiveness and safety of AS in non-endemic areas. Administrative procedures must be accelerated in order to obtain full registration and facilitate access to AS in France.

Keywords: Adverse events; Artesunate; Imported malaria; Malaria; Safety.

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Conflict of interest statement

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript.

Figures

Fig. 1
Fig. 1
Univariate analysis of the number of severity criteria according to age
Fig. 2
Fig. 2
Univariate analysis of the number of AS doses according to the number of severity criteria
Fig. 3
Fig. 3
Univariate analysis of the parasitemia distribution according to the number of severity criteria
See this image and copyright information in PMC

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