Safety, tolerability, and efficacy of high versus low-dose, short versus long-course daily primaquine for the radical cure of uncomplicated Plasmodium vivax malaria in children under 15 years of age: an open-label, non-inferiority, randomized control

High-dose PQ regimens (7.0 mg/kg total) were safe, well tolerated, and significantly reduced P. vivax recurrence in children without G6PD deficiency. Both 7- and 14-day schedules showed comparable efficacy, with rare SAEs and normalization of Hb and methaemoglobinaemia by day 28. Given their similar efficacy, the shorter regimen may offer advantages for adherence and programmatic implementation in endemic settings. Trial registration ClinicalTrials.gov, TRN: NCT05044637, Registration Date: 20 August 2021.

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Publication Details

Journal
Malaria Journal
Published
2025-12-22
DOI
https://doi.org/10.1186/s12936-025-05686-y
Primary Topic
Malaria Research and Control
Type
article
Field-Weighted Citation Impact
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article

Safety, tolerability, and efficacy of high versus low-dose, short versus long-course daily primaquine for the radical cure of uncomplicated Plasmodium vivax malaria in children under 15 years of age: an open-label, non-inferiority, randomized control

Aretha Gomes Omena, Djane Clarys Baía-da-Silva, Flor Ernestina Martínez-Espinosa, Quique Bassat et al.
Malaria Journal
Malaria Research and Control
article

Safety, tolerability, and efficacy of high versus low-dose, short versus long-course daily primaquine for the radical cure of uncomplicated Plasmodium vivax malaria in children under 15 years of age: an open-label, non-inferiority, randomized control

Aretha Gomes Omena, Djane Clarys Baía-da-Silva, Flor Ernestina Martínez-Espinosa, Quique Bassat, Wuelton Monteiro MONTEIRO, Gisely C. Melo, Ingrid G. Souza, Ana Luisa O. Pacheco, Debora C. B. Silva, Suianne C. N. Vale, Laila R. A. Barbosa, Luis O. S. Nogueira, Tyane A. P. Jardim, Adriana P. B. Lopes, Jady S. M. Cordeiro, Valéria D. S. Lima, Vanderson S. Sampaio, Maria Paula G. Mourão, Renata F. Araujo, Maria Graças C. Alecrim, Jose Diego Brito-Sousa, Marcus V. G. Lacerda
article en

Abstract

High-dose PQ regimens (7.0 mg/kg total) were safe, well tolerated, and significantly reduced P. vivax recurrence in children without G6PD deficiency. Both 7- and 14-day schedules showed comparable efficacy, with rare SAEs and normalization of Hb and methaemoglobinaemia by day 28. Given their similar efficacy, the shorter regimen may offer advantages for adherence and programmatic implementation in endemic settings. Trial registration ClinicalTrials.gov, TRN: NCT05044637, Registration Date: 20 August 2021.

Malaria JournalVol. 25(1)
Institució Catalana de Recerca i Estudis Avançats (ES), Hospital Sant Joan de Déu Barcelona (ES), Universidade Federal do Acre (BR), Duke University (US), Instituto de Salud Carlos III (ES), Fundação de Medicina Tropical (BR), Departament de Salut (ES), Hospital Clínic de Barcelona (ES), Manhiça Health Research Centre (MZ), Duke Institute for Health Innovation (US), Universidade Nilton Lins (BR), Universidade do Estado do Amazonas (BR), Barcelona Institute for Global Health (ES), Universidade Cruzeiro do Sul (BR), Secretaria Municipal de Saúde (BR), Fundação Oswaldo Cruz (BR), The University of Texas Medical Branch at Galveston (US), Universitat de Barcelona (ES)
Good health and well-being
Openalex Percentile: Top 28%
Malaria Research and Control
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