@article{fdi:010065420, title = {{A}rtesunate-amodiaquine versus artemether-lumefantrine for the treatment of acute uncomplicated malaria in {C}ongolese children under 10 years old living in a suburban area : a randomized study}, author = {{N}dounga, {M}. and {M}ayengue, {P}. {I}. and {C}asimiro, {P}. {N}. and {K}oukouikila-{K}oussounda, {F}. and {B}itemo, {M}. and {M}atondo, {B}. {D}. and {D}iakou, {L}. {A}. {N}. and {B}asco, {L}eonardo and {N}toumi, {F}.}, editor = {}, language = {{ENG}}, abstract = {{B}ackground: {T}he {R}epublic of {C}ongo adopted a new anti-malarial treatment policy in 2006, with artesunate-amodiaquine ({ASAQ}) and artemether-lumefantrine ({AL}) as the first-and second-line anti-malarial drugs, respectively. {O}nly three clinical studies had been conducted before the policy change. {A} randomized study on these two artemisinin-based combinations was conducted, and the effect that sickle cell trait may have on treatment outcomes was evaluated in children under 10 years old followed during 12 months in {B}razzaville in 2010-2011. {M}ethods: {A} cohort of 330 children under 10 years of age living in a suburban area in the south of {B}razzaville were passively followed for registration of malaria episodes. {U}ncomplicated {P}lasmodium falciparum episodes were randomly treated with co-formulated {ASAQ} ({C}oarsucam ({R})) or {AL} ({C}oartem ({R})). {P}atients were followed according to the 2009 {W}orld {H}ealth {O}rganization protocol for the evaluation of anti-malarial drug efficacy. {P}lasmodium falciparum recrudescent isolates were compared to pre-treatment isolates by polymerase chain reaction ({PCR}) to distinguish between re-infection and recrudescence. {PCR}-uncorrected and {PCR}-corrected responses to treatment were determined using per protocol analysis. {H}aemoglobin type ({AA}, {AS}, {SS}) was determined by {PCR}. {R}esults: {O}f 282 clinical malaria episodes registered during 1-year follow-up period, 262 children with uncomplicated malaria were treated with {ASAQ} (129 patients) or {AL} (133 patients). {T}he {PCR}-corrected efficacy, expressed as the percentage of adequate clinical and parasitological response, was 97.0 % for {ASAQ} and 96.4 % for {AL}. {A}mong {ASAQ}-treated patients, 112 (86.8 %) carried {AA} genotype and 17 (13.2 %) were {AS} carriers. {T}he {PCR}-corrected efficacy was 96.4 % for {AA}-carriers and 100 % for {AS}-carriers treated with {ASAQ} [relative risk ({RR}) = 0.96; 95 % confidence interval, 0.93-1.00, p = 0.5]. {A}mong 133 {AL}-treated children, 109 (82 %) carried {AA}, and 24 (18 %) {AS} genotypes. {T}he {PCR}-corrected efficacy was 96.7 % among {AA}-carriers and 95.2 % among {AS}-carriers [{RR} = 1.01 (0.92-1.12), p = 0.6]. {N}ausea, jaundice, headache, dizziness, vomiting, pruritus, abdominal pain, and diarrhoea were registered as adverse events in both groups. {ASAQ} was associated with significantly more frequent adverse events ({P} < 0.05). {C}onclusion: {T}his first randomized study in {B}razzaville confirmed the excellent efficacy of these co-formulated antimalarial drugs in children. {S}ickle cell genotype did not influence the treatment efficacy of artemisinin-based combination therapy.}, keywords = {{D}rug resistance ; {A}rtemisinin-based combination therapy ; {S}ickle cell trait ; {D}rug efficacy ; {C}ongo-{B}razzaville ; {CONGO}}, booktitle = {}, journal = {{M}alaria {J}ournal}, volume = {14}, numero = {}, pages = {art. 423 [11 p.]}, ISSN = {1475-2875}, year = {2015}, DOI = {10.1186/s12936-015-0918-6}, URL = {https://www.documentation.ird.fr/hor/fdi:010065420}, }