scholarly journals A 12-week open-label, randomized, controlled trial and 24-week extension to assess the efficacy and safety of fluticasone propionate/formoterol in children with asthma

2016 ◽  
Vol 10 (4) ◽  
pp. 324-337 ◽  
Author(s):  
Andrzej Emeryk ◽  
Rabih Klink ◽  
Tammy McIver ◽  
Prashant Dalvi
Keyword(s):  
Randomized Controlled Trial ◽  
Fluticasone Propionate ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled ◽  
Children With Asthma

scholarly journals Efficacy and safety of artesunate-amodiaquine and artemether-lumefantrine and prevalence of molecular markers associated with resistance, Guinea: an open-label two-arm randomized controlled trial

2020 ◽  
Author(s):  
Abdoul Habib Beavogui ◽  
Alioune Camara ◽  
Alexandre Delamou ◽  
Abdoulaye Doumbouya ◽  
Karifa Kourouma ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Molecular Markers ◽  
Treatment Failure ◽  
Uncomplicated Malaria ◽  
Controlled Trial ◽  
Artemisinin Resistance ◽  
Efficacy And Safety ◽  
Open Label ◽  
Randomized Controlled ◽  
Kaplan Meier

Abstract ​ Background: Antimalarial resistance is a threat to recent gains in malaria control. This study aimed to assess the efficacy and safety of artesunate-amodiaquine (ASAQ) and artemether-lumefantrine (AL) in the management of uncomplicated malaria and to measure the prevalence of molecular markers of resistance of Plasmodium falciparum in sentinel sites in Maferinyah and Labé Health Districts in Guinea in 2016. Methods: This was a two-arm randomized controlled trial of the efficacy of AL and ASAQ among children aged 6-59 months with uncomplicated P. falciparum malaria in two sites. Children were followed for 28 days to assess clinical and parasitological response. The primary outcome was the Kaplan-Meier estimate of Day 28 (D28) efficacy after correction by microsatellite-genotyping. Pre-treatment (D0) and day of failure samples were assayed for molecular markers of resistance in the pfk13 and pfmdr1 genes. Results: A total of 421 participants were included with 211 participants in the Maferinyah site and 210 in Labé. No early treatment failure was observed in any study arms. However, 22 (5.3%) participants developed a late treatment failure (8 in the ASAQ arm and 14 in the AL arm), which were further classified as 2 recrudescences and 20 reinfections. The Kaplan-Meier estimate of the corrected efficacy at D28 was 100% for both AL and ASAQ in Maferinyah site and 99% (95% Confidence Interval: 97.2-100%) for ASAQ and 99% (97.1-100%) for AL in Labé. The majority of successfully analyzed D0 (98%, 380/389) and all day of failure (100%, 22/22) samples were wild type for pfk13 . All 9 observed pfk13 mutations were polymorphisms not associated with artemisinin resistance. The NFD haplotype was the predominant haplotype in both D0 (197/362, 54%) and day of failure samples (11/18, 61%) successfully analyzed for pfmdr1 . Vomiting was the most common observed side effect (14%) across all arms. Conclusions: This study observed high efficacy and safety of both ASAQ and AL in Guinea, providing evidence for their continued use to treat uncomplicated malaria. Continued monitoring of ACT efficacy and safety and molecular makers of resistance in Guinea is important to detect emergence of parasite resistance and to inform evidence-based malaria treatment policies.

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