PMID- 35189818
OWN - NLM
STAT- MEDLINE
DCOM- 20220223
LR  - 20220225
IS  - 1471-2334 (Electronic)
IS  - 1471-2334 (Linking)
VI  - 22
IP  - 1
DP  - 2022 Feb 21
TI  - Effectiveness and safety of artesunate-amodiaquine versus artemether-lumefantrine 
      for home-based treatment of uncomplicated Plasmodium falciparum malaria among 
      children 6-120 months in Yaounde, Cameroon: a randomized trial.
PG  - 166
LID - 10.1186/s12879-022-07101-2 [doi]
LID - 166
AB  - BACKGROUND: Many studies have reported high efficacy and safety of 
      artesunate-amodiaquine (AS-AQ) and artemether-lumefantrine (AL) when administered 
      under direct observation in Cameroon. There is paucity of data to support their 
      continuous use in home-based treatment of uncomplicated Plasmodium falciparum 
      malaria in Cameroon. Hence, this study aimed to assess the effectiveness and 
      safety of AS-AQ versus AL for home-based treatment of uncomplicated P. falciparum 
      malaria among children 6-120 months in Yaounde, Cameroon. METHODS: A two-arm, 
      open-label, randomized, controlled trial comparing the equivalence of AS-AQ 
      (experimental group) and AL (control group) was carried out from May 2019 to 
      April 2020 at two secondary hospitals in Yaounde. Participants were randomized to 
      receive either AS-AQ or AL. After the first dose, antimalarial drugs were given 
      at home, rather than under direct observation by a study staff. The conventional 
      on-treatment and post-treatment laboratory and clinical evaluations were not done 
      until day 3 of the full antimalarial treatment course. The evaluation of 
      effectiveness was mainly based on per protocol polymerase chain reaction adjusted 
      adequate clinical and parasitological response (PP PCR adjusted ACPR) on day 28 
      post-treatment. Safety was based on assessment of adverse events (AEs) and severe 
      adverse events (SAEs) from day 1 to day 28. RESULTS: A total of 242 children were 
      randomized to receive AS-AQ (n = 114) and AL (n = 128). The PP PCR adjusted day 
      28 cure rates were [AS-AQ = 96.9% (95% CI, 91.2-99.4) versus AL = 95.5% (95% CI, 
      89.9-98.5), P = 0.797]. Expected mild to moderate adverse events were reported in 
      both arms [AS-AQ = 83 (84.7%) versus AL = 99 (86.1%), P = 0.774]. The most common 
      adverse events included: transient changes of hematologic indices and fever. 
      CONCLUSIONS: This study demonstrated that AS-AQ and AL are effective and safe for 
      home management of malaria in Yaounde. The evidence from this study supports the 
      parallel use of the two drugs in routine practice. However, the findings from 
      this study do not describe the likely duration of antimalarial effectiveness in 
      holoendemic areas where multiple courses of treatment might be required. TRIAL 
      REGISTRATION: This study is a randomized controlled trial and it was 
      retrospectively registered on 23/09/2020 at ClinicalTrials.gov with registration 
      number NCT04565184.
CI  - (c) 2022. The Author(s).
FAU - Niba, Peter Thelma Ngwa
AU  - Niba PTN
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Nji, Akindeh Mbuh
AU  - Nji AM
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Ali, Innocent Mbulli
AU  - Ali IM
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Dschang, Dschang, 
      Cameroon.
FAU - Akam, Lawrence Fonyonga
AU  - Akam LF
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Dongmo, Cedric Hermann
AU  - Dongmo CH
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
AD  - Department of Biochemistry, Faculty of Medicine and Biomedical Sciences, 
      University of Yaounde I, Yaounde, Cameroon.
FAU - Chedjou, Jean Paul Kengne
AU  - Chedjou JPK
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Fomboh, Calvino Tah
AU  - Fomboh CT
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Nana, William Dorian
AU  - Nana WD
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
FAU - Oben, Ornella Laetitia Ayem
AU  - Oben OLA
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
FAU - Selly-Ngaloumo, Abdel Aziz
AU  - Selly-Ngaloumo AA
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Moyeh, Marcel N
AU  - Moyeh MN
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry and Molecular Biology, Faculty of Science, University 
      of Buea, Buea, Cameroon.
FAU - Ngu, Jude Achidi
AU  - Ngu JA
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
FAU - Ludovic, Ambassa Jean
AU  - Ludovic AJ
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
AD  - District Hospital, Cite Verte, Yaounde, Cameroon.
FAU - Aboh, Pierre Martiniel
AU  - Aboh PM
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
FAU - Ambani, Marie Carine Enyegue
AU  - Ambani MCE
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
AD  - District Hospital, Ntui, Center Region, Cameroon.
FAU - Omgba, Pierrette Albertine Mbarga
AU  - Omgba PAM
AD  - District Hospital, Cite Verte, Yaounde, Cameroon.
AD  - Jamot Hospital, Yaounde, Cameroon.
FAU - Kotcholi, Grace Bissohong
AU  - Kotcholi GB
AD  - District Hospital, Cite Verte, Yaounde, Cameroon.
FAU - Adzemye, Linus Moye
AU  - Adzemye LM
AD  - District Hospital, Cite Verte, Yaounde, Cameroon.
FAU - Nna, Danielle Regine Abenkou
AU  - Nna DRA
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
FAU - Douanla, Adele
AU  - Douanla A
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
FAU - Ango, Ze
AU  - Ango Z
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
FAU - Ewane, Marie Sophie
AU  - Ewane MS
AD  - District Medical Center, Minkoa-Meyos, Yaounde, Cameroon.
FAU - Ticha, Joel Tewara
AU  - Ticha JT
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
FAU - Tatah, Fritz Mbuh
AU  - Tatah FM
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
FAU - Dinza, Golwa
AU  - Dinza G
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
FAU - Ndikum, Valentine Nchafor
AU  - Ndikum VN
AD  - Department of Pharmacology and African Traditional Medicine, Faculty of Medicine 
      and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon.
FAU - Fosah, Dorothy A
AU  - Fosah DA
AD  - National Malaria Control Program, Ministry of Public Health, Yaounde, Cameroon.
FAU - Bigoga, Jude D
AU  - Bigoga JD
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon.
AD  - Department of Biochemistry, Faculty of Science, University of Yaounde I, Yaounde, 
      Cameroon.
FAU - Alifrangis, Michael
AU  - Alifrangis M
AD  - Centre for Medical Parasitology, Department of Immunology and Microbiology, 
      Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, 
      Denmark.
AD  - Department of Infectious Diseases, Copenhagen University Hospital, Copenhagen, 
      Denmark.
FAU - Mbacham, Wilfred F
AU  - Mbacham WF
AD  - MARCAD-DELTAS Program, Laboratory for Public Health Research Biotechnologies, 
      University of Yaounde I, Yaounde, Cameroon. wfmbacham@yahoo.com.
AD  - The Biotechnology Center, University of Yaounde I, Yaounde, Cameroon. 
      wfmbacham@yahoo.com.
AD  - Cameroon Coalition Against Malaria, P.O. Box 8094, Yaounde, Cameroon. 
      wfmbacham@yahoo.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT04565184
GR  - grant # DEL-15-010/AAS/AESA/Wellcome trust UK/
GR  - grant # DEL-15-010/AAS/AESA/Wellcome trust UK/
GR  - grant # DEL-15-010/AAS/AESA/Wellcome trust UK/
GR  - grant # DEL-15-010/AAS/AESA/Wellcome trust UK/
GR  - grant # DEL-15-010/AAS/AESA/Wellcome trust UK/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20220221
PL  - England
TA  - BMC Infect Dis
JT  - BMC infectious diseases
JID - 100968551
RN  - 0 (Antimalarials)
RN  - 0 (Artemether, Lumefantrine Drug Combination)
RN  - 0 (Artemisinins)
RN  - 0 (Drug Combinations)
RN  - 0 (Ethanolamines)
RN  - 220236ED28 (Amodiaquine)
RN  - 60W3249T9M (Artesunate)
RN  - C7D6T3H22J (Artemether)
SB  - IM
MH  - Amodiaquine/adverse effects
MH  - *Antimalarials/adverse effects
MH  - Artemether/therapeutic use
MH  - Artemether, Lumefantrine Drug Combination/therapeutic use
MH  - *Artemisinins/adverse effects
MH  - Artesunate/therapeutic use
MH  - Cameroon
MH  - Child
MH  - Drug Combinations
MH  - Ethanolamines/adverse effects
MH  - Humans
MH  - Infant
MH  - *Malaria, Falciparum/drug therapy
MH  - Plasmodium falciparum
MH  - Treatment Outcome
PMC - PMC8862275
OTO - NOTNLM
OT  - Artemether-lumefantrine
OT  - Artesunate-amodiaquine
OT  - Cameroon
OT  - Effectiveness
OT  - Malaria
OT  - Plasmodium falciparum
OT  - Safety
COIS- The authors declare that they have no competing interests.
EDAT- 2022/02/23 06:00
MHDA- 2022/02/24 06:00
PMCR- 2022/02/21
CRDT- 2022/02/22 05:42
PHST- 2021/05/13 00:00 [received]
PHST- 2022/01/29 00:00 [accepted]
PHST- 2022/02/22 05:42 [entrez]
PHST- 2022/02/23 06:00 [pubmed]
PHST- 2022/02/24 06:00 [medline]
PHST- 2022/02/21 00:00 [pmc-release]
AID - 10.1186/s12879-022-07101-2 [pii]
AID - 7101 [pii]
AID - 10.1186/s12879-022-07101-2 [doi]
PST - epublish
SO  - BMC Infect Dis. 2022 Feb 21;22(1):166. doi: 10.1186/s12879-022-07101-2.