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Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial

Standard

Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial. / Adegbite, Bayode R.; Edoa, Jean R.; Honkpehedji, Yabo J.; Zinsou, Frejus J.; Dejon-Agobe, Jean C.; Mbong-Ngwese, Mirabeau; Lotola-Mougueni, Fabrice; Koehne, Erik; Lalremruata, Albert; Kreidenweiss, Andrea; Nguyen, The T.; Kun, Jutta; Agnandji, Selidji T.; Lell, Bertrand; Safiou, Abdou R.; Obone Atome, Fridia A.; Mombo-Ngoma, Ghyslain; Ramharter, Michael; Velavan, Thirumalaisamy P.; Mordmüller, Benjamin; Kremsner, Peter G.; Adegnika, Ayola A.

In: MALARIA J, Vol. 18, No. 1, 424, 16.12.2019.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Adegbite, BR, Edoa, JR, Honkpehedji, YJ, Zinsou, FJ, Dejon-Agobe, JC, Mbong-Ngwese, M, Lotola-Mougueni, F, Koehne, E, Lalremruata, A, Kreidenweiss, A, Nguyen, TT, Kun, J, Agnandji, ST, Lell, B, Safiou, AR, Obone Atome, FA, Mombo-Ngoma, G, Ramharter, M, Velavan, TP, Mordmüller, B, Kremsner, PG & Adegnika, AA 2019, 'Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial', MALARIA J, vol. 18, no. 1, 424. https://doi.org/10.1186/s12936-019-3015-4

APA

Adegbite, B. R., Edoa, J. R., Honkpehedji, Y. J., Zinsou, F. J., Dejon-Agobe, J. C., Mbong-Ngwese, M., Lotola-Mougueni, F., Koehne, E., Lalremruata, A., Kreidenweiss, A., Nguyen, T. T., Kun, J., Agnandji, S. T., Lell, B., Safiou, A. R., Obone Atome, F. A., Mombo-Ngoma, G., Ramharter, M., Velavan, T. P., ... Adegnika, A. A. (2019). Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial. MALARIA J, 18(1), [424]. https://doi.org/10.1186/s12936-019-3015-4

Vancouver

Adegbite BR, Edoa JR, Honkpehedji YJ, Zinsou FJ, Dejon-Agobe JC, Mbong-Ngwese M et al. Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial. MALARIA J. 2019 Dec 16;18(1). 424. https://doi.org/10.1186/s12936-019-3015-4

Bibtex

@article{0df62aeba1cd4c78aa3a8c9150c8f2d5,
title = "Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambar{\'e}n{\'e}, Gabon: an open-label clinical trial",
abstract = "Background: Malaria remains a major public health problem, affecting mainly low-and middle-income countries. The management of this parasitic disease is challenged by ever increasing drug resistance. This study, investigated the therapeutic efficacy, tolerability and safety of artemether-lumefantrine (AL) and artesunate-amodiaquine (AS-AQ), used as first-line drugs to treat uncomplicated malaria in Lambar{\'e}n{\'e}, Gabon. Methods: A non-randomized clinical trial was conducted between October 2017 and March 2018 to assess safety, clinical and parasitological efficacy of fixed-doses of AL and AS-AQ administered to treat uncomplicated Plasmodium falciparum malaria in children aged from 6 months to 12 years. After 50 children were treated with AL, another 50 children received ASAQ. The 2009 World Health Organization protocol for monitoring of the efficacy of antimalarial drugs was followed. Molecular markers msp1 and msp2 were used to differentiate recrudescence and reinfection. For the investigation of artemisinin resistant markers, gene mutations in Pfk13 were screened. Results: Per-protocol analysis on day 28 showed a PCR corrected cure rate of 97% (95% CI 86-100) and 95% (95% CI 84-99) for AL and AS-AQ, respectively. The most frequent adverse event in both groups was asthenia. No mutations in the kelch-13 gene associated with artemisinin resistance were identified. All participants had completed microscopic parasite clearance by day 3 post-treatment. Conclusion: This study showed that AL and AS-AQ remain efficacious, well-tolerated, and are safe to treat uncomplicated malaria in children from Lambar{\'e}n{\'e}. However, a regular monitoring of efficacy and a study of molecular markers of drug resistance to artemisinin in field isolates is essential. Trial registration ANZCTR, ACTRN12616001600437. Registered 18 November, http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12616001600437p&isBasic=True",
keywords = "Artemether-lumefantrine, Artesunate-amodiaquine, Efficacy, Gabon, Lambar{\'e}n{\'e}, Malaria, Safety, Tolerability",
author = "Adegbite, {Bayode R.} and Edoa, {Jean R.} and Honkpehedji, {Yabo J.} and Zinsou, {Frejus J.} and Dejon-Agobe, {Jean C.} and Mirabeau Mbong-Ngwese and Fabrice Lotola-Mougueni and Erik Koehne and Albert Lalremruata and Andrea Kreidenweiss and Nguyen, {The T.} and Jutta Kun and Agnandji, {Selidji T.} and Bertrand Lell and Safiou, {Abdou R.} and {Obone Atome}, {Fridia A.} and Ghyslain Mombo-Ngoma and Michael Ramharter and Velavan, {Thirumalaisamy P.} and Benjamin Mordm{\"u}ller and Kremsner, {Peter G.} and Adegnika, {Ayola A.}",
note = "Funding Information: This study was sponsored by Ministry of Health Gabon and funded by WHO (TES 2017_1071_001) as well as the Ministry of Health under EDCTP 2 scope. Publisher Copyright: {\textcopyright} 2019 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.",
year = "2019",
month = dec,
day = "16",
doi = "10.1186/s12936-019-3015-4",
language = "English",
volume = "18",
journal = "MALARIA J",
issn = "1475-2875",
publisher = "BioMed Central Ltd.",
number = "1",

}

RIS

TY - JOUR

T1 - Monitoring of efficacy, tolerability and safety of artemether-lumefantrine and artesunate-amodiaquine for the treatment of uncomplicated Plasmodium falciparum malaria in Lambaréné, Gabon: an open-label clinical trial

AU - Adegbite, Bayode R.

AU - Edoa, Jean R.

AU - Honkpehedji, Yabo J.

AU - Zinsou, Frejus J.

AU - Dejon-Agobe, Jean C.

AU - Mbong-Ngwese, Mirabeau

AU - Lotola-Mougueni, Fabrice

AU - Koehne, Erik

AU - Lalremruata, Albert

AU - Kreidenweiss, Andrea

AU - Nguyen, The T.

AU - Kun, Jutta

AU - Agnandji, Selidji T.

AU - Lell, Bertrand

AU - Safiou, Abdou R.

AU - Obone Atome, Fridia A.

AU - Mombo-Ngoma, Ghyslain

AU - Ramharter, Michael

AU - Velavan, Thirumalaisamy P.

AU - Mordmüller, Benjamin

AU - Kremsner, Peter G.

AU - Adegnika, Ayola A.

N1 - Funding Information: This study was sponsored by Ministry of Health Gabon and funded by WHO (TES 2017_1071_001) as well as the Ministry of Health under EDCTP 2 scope. Publisher Copyright: © 2019 The Author(s). Copyright: Copyright 2020 Elsevier B.V., All rights reserved.

PY - 2019/12/16

Y1 - 2019/12/16

N2 - Background: Malaria remains a major public health problem, affecting mainly low-and middle-income countries. The management of this parasitic disease is challenged by ever increasing drug resistance. This study, investigated the therapeutic efficacy, tolerability and safety of artemether-lumefantrine (AL) and artesunate-amodiaquine (AS-AQ), used as first-line drugs to treat uncomplicated malaria in Lambaréné, Gabon. Methods: A non-randomized clinical trial was conducted between October 2017 and March 2018 to assess safety, clinical and parasitological efficacy of fixed-doses of AL and AS-AQ administered to treat uncomplicated Plasmodium falciparum malaria in children aged from 6 months to 12 years. After 50 children were treated with AL, another 50 children received ASAQ. The 2009 World Health Organization protocol for monitoring of the efficacy of antimalarial drugs was followed. Molecular markers msp1 and msp2 were used to differentiate recrudescence and reinfection. For the investigation of artemisinin resistant markers, gene mutations in Pfk13 were screened. Results: Per-protocol analysis on day 28 showed a PCR corrected cure rate of 97% (95% CI 86-100) and 95% (95% CI 84-99) for AL and AS-AQ, respectively. The most frequent adverse event in both groups was asthenia. No mutations in the kelch-13 gene associated with artemisinin resistance were identified. All participants had completed microscopic parasite clearance by day 3 post-treatment. Conclusion: This study showed that AL and AS-AQ remain efficacious, well-tolerated, and are safe to treat uncomplicated malaria in children from Lambaréné. However, a regular monitoring of efficacy and a study of molecular markers of drug resistance to artemisinin in field isolates is essential. Trial registration ANZCTR, ACTRN12616001600437. Registered 18 November, http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12616001600437p&isBasic=True

AB - Background: Malaria remains a major public health problem, affecting mainly low-and middle-income countries. The management of this parasitic disease is challenged by ever increasing drug resistance. This study, investigated the therapeutic efficacy, tolerability and safety of artemether-lumefantrine (AL) and artesunate-amodiaquine (AS-AQ), used as first-line drugs to treat uncomplicated malaria in Lambaréné, Gabon. Methods: A non-randomized clinical trial was conducted between October 2017 and March 2018 to assess safety, clinical and parasitological efficacy of fixed-doses of AL and AS-AQ administered to treat uncomplicated Plasmodium falciparum malaria in children aged from 6 months to 12 years. After 50 children were treated with AL, another 50 children received ASAQ. The 2009 World Health Organization protocol for monitoring of the efficacy of antimalarial drugs was followed. Molecular markers msp1 and msp2 were used to differentiate recrudescence and reinfection. For the investigation of artemisinin resistant markers, gene mutations in Pfk13 were screened. Results: Per-protocol analysis on day 28 showed a PCR corrected cure rate of 97% (95% CI 86-100) and 95% (95% CI 84-99) for AL and AS-AQ, respectively. The most frequent adverse event in both groups was asthenia. No mutations in the kelch-13 gene associated with artemisinin resistance were identified. All participants had completed microscopic parasite clearance by day 3 post-treatment. Conclusion: This study showed that AL and AS-AQ remain efficacious, well-tolerated, and are safe to treat uncomplicated malaria in children from Lambaréné. However, a regular monitoring of efficacy and a study of molecular markers of drug resistance to artemisinin in field isolates is essential. Trial registration ANZCTR, ACTRN12616001600437. Registered 18 November, http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12616001600437p&isBasic=True

KW - Artemether-lumefantrine

KW - Artesunate-amodiaquine

KW - Efficacy

KW - Gabon

KW - Lambaréné

KW - Malaria

KW - Safety

KW - Tolerability

UR - http://www.scopus.com/inward/record.url?scp=85076715128&partnerID=8YFLogxK

U2 - 10.1186/s12936-019-3015-4

DO - 10.1186/s12936-019-3015-4

M3 - SCORING: Journal article

C2 - 31842893

AN - SCOPUS:85076715128

VL - 18

JO - MALARIA J

JF - MALARIA J

SN - 1475-2875

IS - 1

M1 - 424

ER -