Evidence map›Paper›PMID 39785834›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2025

Safety and Efficacy of 3 Alternative Regimens Against Relapsing Plasmodium vivax Malaria in Glucose 6-Phosphate Dehydrogenase-Deficient Patients in the Brazilian Amazon (ALTPRIM).

Laila Barbosa, José Brito-Sousa, Cristiana Nascimento, Ana Pacheco, Márcia Alexandre, Aline Alencar, Marly Melo, Aretha Omena, Ingrid Souza, Emanuelle Silva and 22 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03529396 (Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in Glucose 6-phosphate Dehydrogenase Deficient Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03529396 phase2completednot on this map

Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in Glucose 6-phosphate Dehydrogenase Deficient Patients

TypeinterventionalSponsorFundação de Medicina Tropical Dr. Heitor Vieira DouradoRan2018 to 2023Enrolled106ConditionsVivax Malaria, G6PD DeficiencyArmsChloroquine, Primaquine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors.

Laila BarbosaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0001-8480-0352
José Brito-SousaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0003-1659-3763
Cristiana NascimentoFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Ana PachecoFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0002-1759-2204
Márcia AlexandreFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Aline AlencarFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Marly MeloFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Aretha OmenaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0009-0007-5706-4055
Ingrid SouzaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0009-0003-7767-7079
Emanuelle SilvaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0002-1918-6840
Michael QueirozFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Vitória SiqueiraFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Cristina RabeloFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Djane Baía-da-SilvaFundação Oswaldo Cruz, Instituto Leônidas and Maria Deane, Manaus, Brazil.
Débora SilvaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Yasmin RochaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Antônio BarbosaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Ramon CastroFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Anne AlmeidaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Marcelo BritoFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0001-9134-3970
Adriana LopesFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0001-8722-8216
Antônio BalieiroFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Mônica CostaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Thais AmaralFundação Oswaldo Cruz, Rio de Janeiro, Brazil.ORCID 0000-0002-4092-1707
Cristiane ValleFundação Oswaldo Cruz, Rio de Janeiro, Brazil.ORCID 0009-0001-8542-6486
Alexia VieiraCentro de Pesquisa em Medicina Tropical, Porto Velho, Brazil.ORCID 0009-0002-4975-9301
Jhon GonzagaCentro de Pesquisa em Medicina Tropical, Porto Velho, Brazil.
Dhélio PereiraCentro de Pesquisa em Medicina Tropical, Porto Velho, Brazil.
Maria AlecrimFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Wuelton MonteiroFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.
Marcus LacerdaFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.ORCID 0000-0003-3374-9985
Gisely MeloFundação de Medicina Tropical Dr Heitor Vieira Dourado, Manaus, Brazil.

Funding

Coordenação de Aperfeiçoamento de Pessoal de Nível SuperiorFiocruz 420746/2017-0Fundação de Amparo à Pesquisa do Estado do AmazonasNational Council for Scientific and Technological DevelopmentPOSGRAD/FAPEAM
6 · The paper itself

Abstract

backgroundDaily primaquine-induced hemolysis is a common cause of complications during Plasmodium vivax malaria treatment in individuals with glucose 6-phosphate dehydrogenase deficiency (G6PDd). Alternative regimens balancing safety and efficacy are needed.

methodsG6PDd participants with P. vivax malaria from 2 sites in Brazilian Amazon between 2018 and 2022 were randomly allocated to 3 arms that received chloroquine (CQ) from day 1 to day 3 plus (arm 1) a 7-day course of primaquine (PQ) (0.5 mg/kg/day), beginning at day 5; (arm 2) weekly PQ over 8 weeks (0.75 mg/kg/wk); or (arm 3) weekly CQ over 12 weeks (5 mg/kg/wk). A normal-G6PD participants group was also enrolled in parallel using CQ for 3 days plus PQ for 7 days. The primary focus was safety profile; secondary was the number of patients free from the first recurrence until day 180.

resultsFifty-four G6PDd participants were enrolled. There were 2 participants in arm 1, but the arm was halted due to safety concerns. The weekly PQ group presented higher hemoglobin decreases in day 3 after first dose (Δhemoglobin = -1.61) than the weekly CQ group (Δhemoglobin = -0.99), but efficacy was superior over the 6-month follow-up.

conclusionsPostponing the beginning of daily PQ to day 5, when less oxidative stress related to malaria itself would, in theory, decrease hemolytic effects of the drug in G6PDd patients, was not shown to be safe. Weekly CQ avoiding the first relapse did not stop further relapses. Weekly PQ, as already demonstrated in Southeast Asia, was equally safe and efficacious in patients from Latin America. Clinical Trials Registration. NCT03529396.

Indexed as

AntimalarialsChloroquineGlucosephosphate Dehydrogenase DeficiencyMalaria, VivaxPrimaquineAdolescentAdultBrazilFemaleHemolysisHumansMaleMiddle AgedPlasmodium vivaxRecurrenceTreatment OutcomeAntimalarialsChloroquinePrimaquineG6PD deficiencyhemolysisPlasmodium vivaxprimaquineradical cure

Identifiers

PMID39785834
PMCPMC12728283

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.