Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment

Sze Ann Woon; Brioni R. Moore; Moses Laman; Paula Tesine; Lina Lorry; Bernadine Kasian; Phantica Yambo; Gumul Yadi; William Pomat; Kevin T. Batty; Sam Salman; Leanne J. Robinson; Timothy M.E. Davis; Laurens Manning

doi:10.1016/j.ijid.2023.03.010

Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment

Sze Ann Woon
, Brioni R. Moore
, Moses Laman
, Paula Tesine
, Lina Lorry
, Bernadine Kasian
, Phantica Yambo
, Gumul Yadi
, William Pomat
, Kevin T. Batty
, Sam Salman
, Leanne J. Robinson
, Timothy M.E. Davis
, Laurens Manning

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

Abstract

Objectives: We aimed to assess safety, tolerability, and Plasmodium vivax relapse rates of ultra-short course (3.5 days) high-dose (1 mg/kg twice daily) primaquine (PQ) for uncomplicated malaria because of any Plasmodium species in children randomized to early- or delayed treatment. Methods: Children aged 0.5 to 12 years with normal glucose-6-phosphate-dehydrogenase (G6PD) activity were enrolled. After artemether-lumefantrine (AL) treatment, children were randomized to receive PQ immediately after (early) or 21 days later (delayed). Primary and secondary endpoints were the appearance of any P. vivax parasitemia within 42 or 84 days, respectively. A non-inferiority margin of 15% was applied (ACTRN12620000855921). Results: A total of 219 children were recruited, 70% with Plasmodium falciparum and 24% with P. vivax. Abdominal pain (3.7% vs 20.9%, P

Original language	English
Pages (from-to)	189-195
Number of pages	7
Journal	International Journal of Infectious Diseases
Volume	130
DOIs	https://doi.org/10.1016/j.ijid.2023.03.010
Publication status	Published - May 2023

Funding

Funders	Funder number
NHMRC National Health and Medical Research Council	1130301

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

10.1016/j.ijid.2023.03.010Licence: CC BY-NC-ND

Cite this

Woon, S. A., Moore, B. R., Laman, M., Tesine, P., Lorry, L., Kasian, B., Yambo, P., Yadi, G., Pomat, W., Batty, K. T., Salman, S., Robinson, L. J., Davis, T. M. E., & Manning, L. (2023). Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment. International Journal of Infectious Diseases, 130, 189-195. https://doi.org/10.1016/j.ijid.2023.03.010

@article{b0b9d072ef834e8180ea3e9b2b8f6ca7,

title = "Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment",

abstract = "Objectives: We aimed to assess safety, tolerability, and Plasmodium vivax relapse rates of ultra-short course (3.5 days) high-dose (1 mg/kg twice daily) primaquine (PQ) for uncomplicated malaria because of any Plasmodium species in children randomized to early- or delayed treatment. Methods: Children aged 0.5 to 12 years with normal glucose-6-phosphate-dehydrogenase (G6PD) activity were enrolled. After artemether-lumefantrine (AL) treatment, children were randomized to receive PQ immediately after (early) or 21 days later (delayed). Primary and secondary endpoints were the appearance of any P. vivax parasitemia within 42 or 84 days, respectively. A non-inferiority margin of 15\% was applied (ACTRN12620000855921). Results: A total of 219 children were recruited, 70\% with Plasmodium falciparum and 24\% with P. vivax. Abdominal pain (3.7\% vs 20.9\%, P ",

keywords = "Malaria, Pediatric, Plasmodium falciparum, Plasmodium vivax, Primaquine, Radical cure, Universal cure",

author = "Woon, \{Sze Ann\} and Moore, \{Brioni R.\} and Moses Laman and Paula Tesine and Lina Lorry and Bernadine Kasian and Phantica Yambo and Gumul Yadi and William Pomat and Batty, \{Kevin T.\} and Sam Salman and Robinson, \{Leanne J.\} and Davis, \{Timothy M.E.\} and Laurens Manning",

note = "Funding Information: The study was funded by the National Health and Medical Research Council (GNT1130301). Publisher Copyright: {\textcopyright} 2023",

year = "2023",

month = may,

doi = "10.1016/j.ijid.2023.03.010",

language = "English",

volume = "130",

pages = "189--195",

journal = "International Journal of Infectious Diseases",

issn = "1201-9712",

publisher = "Elsevier",

}

Woon, SA, Moore, BR, Laman, M, Tesine, P, Lorry, L, Kasian, B, Yambo, P, Yadi, G, Pomat, W, Batty, KT, Salman, S, Robinson, LJ, Davis, TME & Manning, L 2023, 'Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment', International Journal of Infectious Diseases, vol. 130, pp. 189-195. https://doi.org/10.1016/j.ijid.2023.03.010

Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment. / Woon, Sze Ann; Moore, Brioni R.; Laman, Moses et al.
In: International Journal of Infectious Diseases, Vol. 130, 05.2023, p. 189-195.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria

T2 - A randomized, open-label, non-inferiority trial of early versus delayed treatment

AU - Woon, Sze Ann

AU - Moore, Brioni R.

AU - Laman, Moses

AU - Tesine, Paula

AU - Lorry, Lina

AU - Kasian, Bernadine

AU - Yambo, Phantica

AU - Yadi, Gumul

AU - Pomat, William

AU - Batty, Kevin T.

AU - Salman, Sam

AU - Robinson, Leanne J.

AU - Davis, Timothy M.E.

AU - Manning, Laurens

PY - 2023/5

Y1 - 2023/5

N2 - Objectives: We aimed to assess safety, tolerability, and Plasmodium vivax relapse rates of ultra-short course (3.5 days) high-dose (1 mg/kg twice daily) primaquine (PQ) for uncomplicated malaria because of any Plasmodium species in children randomized to early- or delayed treatment. Methods: Children aged 0.5 to 12 years with normal glucose-6-phosphate-dehydrogenase (G6PD) activity were enrolled. After artemether-lumefantrine (AL) treatment, children were randomized to receive PQ immediately after (early) or 21 days later (delayed). Primary and secondary endpoints were the appearance of any P. vivax parasitemia within 42 or 84 days, respectively. A non-inferiority margin of 15% was applied (ACTRN12620000855921). Results: A total of 219 children were recruited, 70% with Plasmodium falciparum and 24% with P. vivax. Abdominal pain (3.7% vs 20.9%, P

AB - Objectives: We aimed to assess safety, tolerability, and Plasmodium vivax relapse rates of ultra-short course (3.5 days) high-dose (1 mg/kg twice daily) primaquine (PQ) for uncomplicated malaria because of any Plasmodium species in children randomized to early- or delayed treatment. Methods: Children aged 0.5 to 12 years with normal glucose-6-phosphate-dehydrogenase (G6PD) activity were enrolled. After artemether-lumefantrine (AL) treatment, children were randomized to receive PQ immediately after (early) or 21 days later (delayed). Primary and secondary endpoints were the appearance of any P. vivax parasitemia within 42 or 84 days, respectively. A non-inferiority margin of 15% was applied (ACTRN12620000855921). Results: A total of 219 children were recruited, 70% with Plasmodium falciparum and 24% with P. vivax. Abdominal pain (3.7% vs 20.9%, P

KW - Malaria

KW - Pediatric

KW - Plasmodium falciparum

KW - Plasmodium vivax

KW - Primaquine

KW - Radical cure

KW - Universal cure

UR - https://www.scopus.com/pages/publications/85151254662

U2 - 10.1016/j.ijid.2023.03.010

DO - 10.1016/j.ijid.2023.03.010

M3 - Article

C2 - 36906121

AN - SCOPUS:85151254662

SN - 1201-9712

VL - 130

SP - 189

EP - 195

JO - International Journal of Infectious Diseases

JF - International Journal of Infectious Diseases

ER -

Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment

Abstract

Funding

UN SDGs

Access to Document

Other files and links

Fingerprint

Enhancing clinical management of paediatric malaria in endemic areas with transmission of multiple Plasmodium species

Cite this

Ultra-short course, high-dose primaquine to prevent Plasmodium vivax infection following uncomplicated pediatric malaria: A randomized, open-label, non-inferiority trial of early versus delayed treatment

Abstract

Funding

UN SDGs

Access to Document

Other files and links

Fingerprint

Projects

Enhancing clinical management of paediatric malaria in endemic areas with transmission of multiple Plasmodium species

Cite this