@article{fdi:010083824, title = {{I}ntravenous artesunate for the treatment of severe imported malaria : implementation, efficacy, and safety in 1391 patients}, author = {{R}oussel, {C}. and {N}dour, {P}. {A}. and {K}endjo, {E}. and {L}arreche, {S}. and {T}aieb, {A}. and {H}enry, {B}. and {L}ebrun-{V}ignes, {B}. and {C}hambrion, {C}. and {A}rgy, {N}. and {H}ouze, {S}. and {M}ouri, {O}. and {C}ourtin, {D}avid and {A}ngoulvant, {A}. and {D}elacour, {H}. and {G}ay, {F}. and {S}iriez, {J}. {Y}. and {D}anis, {M}. and {B}runeel, {F}. and {B}ouchaud, {O}. and {C}aumes, {E}. and {P}iarroux, {R}. and {T}hellier, {M}. and {J}aureguiberry, {S}. and {B}uffet, {P}. and {F}rench {A}rtesunate {W}orking {G}roup}, editor = {}, language = {{ENG}}, abstract = {{B}ackground. {I}ntravenous artesunate is the {W}orld {H}ealth {O}rganization-recommended first-line treatment for severe malaria worldwide, but it is still not fully licensed in {E}urope. {O}bservational studies documenting its safety and efficacy in imported malaria are thus essential. {M}ethods. {W}e prospectively collected clinical and epidemiological features of 1391 artesunate-treated patients among 110 participant centers during the first 7 years (2011-2017) of a national program implemented by the {F}rench {D}rug {A}gency. {R}esults. {A}rtesunate became the most frequent treatment for severe malaria in {F}rance, rising from 9.9% in 2011 to 71.4% in 2017. {M}ortality was estimated at 4.1%. {T}reatment failure was recorded in 27 patients, but mutations in the {K}elch-13 gene were not observed. {M}ain reported adverse events ({AE}s) were anemia (136 cases), cardiac events (24, including 20 episodes of conduction disorders and/or arrhythmia), and liver enzyme elevation (23). {M}ortality and {AE}s were similar in the general population and in people with human immunodeficiency virus, who were overweight, or were pregnant, but the only pregnant woman treated in the first trimester experimented a hemorrhagic miscarriage. {T}he incidence of post-artesunate-delayed hemolysis ({PADH}) was 42.8% when specifically assessed in a 98-patient subgroup, but was not associated with fatal outcomes or sequelae. {PADH} was twice as frequent in patients of {E}uropean compared with {A}frican origin. {C}onclusions. {A}rtesunate was rapidly deployed and displayed a robust clinical benefit in patients with severe imported malaria, despite a high frequency of mild to moderate {PADH}. {F}urther explorations in the context of importation should assess outcomes during the first trimester of pregnancy and collect rare but potentially severe cardiac {AE}s.}, keywords = {severe malaria ; artesunate ; post-artesunate-delayed hemolysis ; safety ; {FRANCE}}, booktitle = {}, journal = {{C}linical {I}nfectious {D}iseases}, volume = {73}, numero = {10}, pages = {1795--1804}, ISSN = {1058-4838}, year = {2021}, DOI = {10.1093/cid/ciab133}, URL = {https://www.documentation.ird.fr/hor/fdi:010083824}, }