Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2019 Dec 16;18(1):424.
doi: 10.1186/s12936-019-3015-4.

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

Bayode R Adegbite  1 , Jean R Edoa  1 , Yabo J Honkpehedji  1   2 , Frejus J Zinsou  1   2 , Jean C Dejon-Agobe  1   3 , Mirabeau Mbong-Ngwese  1 , Fabrice Lotola-Mougueni  1 , Erik Koehne  1   4 , Albert Lalremruata  1   4 , Andrea Kreidenweiss  1   4 , The T Nguyen  4   5 , Jutta Kun  4 , Selidji T Agnandji  1   4 , Bertrand Lell  1   6 , Abdou R Safiou  7 , Fridia A Obone Atome  8 , Ghyslain Mombo-Ngoma  1   4   9   10 , Michael Ramharter  1   9   10 , Thirumalaisamy P Velavan  4   5 , Benjamin Mordmüller  1   4   11 , Peter G Kremsner  1   4   11 , Ayola A Adegnika  12   13   14   15
Affiliations
Clinical Trial

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

Bayode R Adegbite et al. Malar J. .

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 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 anti‑malarial 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.

Keywords: Artemether–lumefantrine; Artesunate–amodiaquine; Efficacy; Gabon; Lambaréné; Malaria; Safety; Tolerability.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Details on study inclusion and follow up progress
Fig. 2
Fig. 2
Kaplan–Meier curves showing treatment success cumulative proportion up to day 28 of follow-up PCR uncorrected and PCR-corrected for AL and AS–AQ
Fig. 3
Fig. 3
Proportion of participants with fever during the follow-up
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

See all "Cited by" articles

References

    1. World Health Organization (WHO). World malaria report 2018. Geneva: World Health Organisation; 2018. http://www.who.int/malaria/en/. Accessed 27 Jan 2019.
    1. WHO. Gabon, country profile. Geneva: World Health Organization; 2018. https://www.who.int/malaria/publications/country-profiles/profile_gab_en.... Accessed 17 Apr 2019.
    1. WHO. Antimalarial drug combination therapy report of a WHO technical consultation. Geneva: World Health Organization; 2001. https://apps.who.int/iris/bitstream/handle/10665/66952/WHO_CDS_RBM_2001?.... Accessed 27 Jan 2019.
    1. Noedl H, Se Y, Schaecher K, Smith BL, Socheat D, Fukuda MM. Evidence of artemisinin-resistant malaria in Western Cambodia. N Engl J Med. 2008;359:2619–2620. doi: 10.1056/NEJMc0805011. - DOI - PubMed
    1. Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, et al. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009;361:455–467. doi: 10.1056/NEJMoa0808859. - DOI - PMC - PubMed

Publication types

Grants and funding