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Malaria, VivaxPhase 2CHILDPRIMNCT05044637

Study to Evaluate Primaquine for Radical Cure of Uncomplicated Plasmodium Vivax Malaria in Children

A Phase 2 study testing Primaquine in people with Malaria, Vivax, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The main determinant of primaquine efficacy is the total dose of primaquine administered, rather than the dosing schedule. Infants and children younger than 4 years of age are at a higher risk of frequent relapses than older age groups, which may lead to severe anaemia. Read more about this study

Who is it for?
Ages 6 months to 14 years
Conditions the study is for
Malaria, Vivax
What is being tested?
Primaquine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesBrazil
Study dates
26 Aug 2021to 7 Jan 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infection with P.vivax parasitaemia;
  • ≥ 6 months and ˂ 15 years of age;
  • Body weight ≥ 5 Kg;
  • Hb > 7 g/dL
  • presence of axillary temperature >37.5 Celsius or history of fever during the past 48 hours;
  • ability to swallow oral medication;
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  • Absence of severe malnutrition (defined as a child whose growth standard is below -3-Z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 110 mm)
  • Absence of febrile conditions due to disease other than malaria (e.g., measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or the known underlying chronic or severe diseases (e.g., cardiac, renal, hepatic diseases, HIV/AIDS);
  • History of hypersensitivity reactions to or contraindicated for any of the medicine(s) being teste d or used as alternative treatment(s);
  • A negative pregnancy test or non-lactating
  • Ability and willingness to comply with the study protocol for the duration of the study, including 6 months of follow up;
  • Informed consent from the patient/parent/guardian (with additional informed assent for any participant between 7 and 14 years of age);
  • Pregnancy test consent from girls of childbearing age (defined as having had menarche) and their parents or guardians;

Who cannot join

  • G6PD- Deficiency (< 4.0 U/g Hb)
  • The subject has severe P. vivax malaria as defined by the World Health Organization (WHO) criteria
  • intolerance of or allergy to one of the medications in the study
  • Pregnant or breastfeeding women
  • Inability to tolerate oral medication
  • Blood tranfusion in the last 3 months (as this may mask the G6PD deficiency)
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  • Serious or chronic medical condition (cardiac, renal, hepatic diseases, sickle cell disease, HIV/AIDS)
  • History of malaria in the last 30 days
  • Belonging to the indigenous community

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Universidade Federal do Acre

    Cruzeiro do Sul, Acre

  • Fundação de Medicina Tropical Doutor Heitor Vieira Dourado

    Manaus, Amazonas, 69040-000

Other trials in Brazil

About this study

Official title: Phase IIB Study to Evaluate Primaquine Safety and Tolerability for Radical Cure of Uncomplicated Plasmodium Vivax Malaria in Children < 15 Years-old (CHILDPRIM)

The main determinant of primaquine efficacy is the total dose of primaquine administered, rather than the dosing schedule. Infants and children younger than 4 years of age are at a higher risk of frequent relapses than older age groups, which may lead to severe anaemia. In view of this issue, after Glucose-6-phosphate dehydrogenase (G6PD) testing, WHO recommends the use of a low dose (0·25 mg/kg of bodyweight) of primaquine for 14 days in infants aged 6 months and older, as a follow-up treatment for malaria caused by P. vivax and P. ovale. Nevertheless, previous trials have demonstrated that the standard low dose regimen of primaquine (3.5 mg/kg total) fails to prevent relapses in many different endemic locations. For this reason, the 2010 WHO antimalarial guidelines now recommend a high dose regimen of 7 mg/kg (equivalent to an adult dose of 30mg per day), although many countries still recommend lower doses for fear of causing more serious harm to unscreened G6PD deficiency patients.

The pharmacokinetics of several antimalarial drugs are different in children younger than 10 years of age or who are underweight for their age compared with children of 10 years and older and adults.The doses of several antimalarials in children are suboptimal. This oversight is a consequence of designing dosing regimens in a different population (i.e., adults) for the one most affected by the disease and this has led to revisions of some dosing recommendations. The different pharmacokinetic performance of drugs in children might also relate to maturation (e.g., of metabolic processes, particularly in the first 2 years of life). Pharmacogenomic factors affecting drug metabolism are increasingly being studied. Polymorphisms in cytochrome P4502D6 are associated with different primaquine metabolizer phenotypes with resulting differing efficacies for radical cure. Shorter courses of higher daily doses of primaquine have the potential to improve adherence and, thus, effectiveness without compromising efficacy. If the efficacy, tolerability and safety of short-course, high-dose primaquine regimens can be assured across the range of endemic settings, along with reliable point-of-care G6PD deficiency diagnostics, then this would be a major advance in malaria treatment by improving adherence and thus the effectiveness of anti-relapse therapy.

Conditions
Malaria, Vivax
Being tested
Primaquine
Medical subject headings
Malaria, Vivax

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PrimaquineDrug

    Also called Low-standard dose

    7 days of unsupervised primaquine (3.5 mg/kg total dose) administered once per day (0.5 mg/kg OD).

  • PrimaquineDrug

    Also called High-dose short course

    7 days of unsupervised primaquine (7.0 mg/kg total dose) administered once per day (1.0 mg/kg OD).

  • PrimaquineDrug

    Also called High-dose long course

    14 days of unsupervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg).

Study groups in NCT05044637
Study groupRoleWhat they receive
Primaquine (3.5mg x 7d)ExperimentalPrimaquine 7 days Standard blood schizontocidal therapy plus 7 days of unsupervised primaquine (3.5 mg/kg total dose) administered once per day (0.5 mg/kg OD).
Receives: Drug: Primaquine
Primaquine (7.0mg x 7d)Active comparatorPrimaquine 7 days Standard blood schizontocidal therapy plus 7 days of unsupervised primaquine (7.0 mg/kg total dose) administered once per day (1.0 mg/kg OD).
Receives: Drug: Primaquine
Primaquine (7.0mg x 14d)Active comparatorPrimaquine 14 days Standard blood schizontocidal therapy plus 14 days of unsupervised primaquine (7.0 mg/kg total dose) administered once per day (0.5 mg/kg).
Receives: Drug: Primaquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety - Adverse Event

    To diagnose, resolve and catalog adverse events of any intensity, whether clinical or laboratory

    Measured: 6 months after randomization

  2. Efficacy - Radical cure

    The incidence rate (i.e., per person-year) of symptomatic recurrent P. vivax parasitaemia (detected by microscopy) over 6 months of follow-up in the 3.5 mg/Kg total dose versus 7.0 mg/Kg total dose primaquine groups

    Measured: 6 months after randomization

Secondary outcomes (9)

  1. Incidence rate (per person-year) of recurrent P. vivax

    The overall incidence rate (per person-year) of any recurrent P. vivax parasitaemia detected by microscopy over 6 months of follow-up in the 3.5 mg/Kg total dose group versus the 7.0 mg/Kg total dose groups

    Measured: 6 months after randomization

  2. Incidence risk of any recurrent symptomatic P. vivax malaria

    The incidence rate (per person-year) of any recurrent symptomatic P. vivax parasitaemia over 6 months of follow-up in either the 7-day or the 14-day primaquine arms of 7.0 mg/kg total dose compared with 7-day primaquine arm of 3.5 mg/Kg total dose.

    Measured: 6 months after randomization

  3. The hematological recovery in patients with vivax malaria

    Hematological recovery will be assessed as the incidence risk of severe anaemia (Hb<7g/dl) and/or blood transfusion within the 6 month follow up period, and the mean fall in baseline Hb on day 7 and day 14. These outcomes will be compared between the treatment arms

    Measured: 6 months after randomization

  4. Proportion of patients with any adverse drug reactions

    The proportion of patients with one or more adverse drug reactions within 42 days of their primary treatment and also at 6 months

    Measured: 6 months after randomization

  5. Primaquine tolerability 1 hour

    Tolerability of primaquine will be assessed by comparing the proportion of patients with nausea, vomiting, abdominal pain and vomiting of a dose within 1 hour of administration between the treatment arms

    Measured: 7 to 14 days after randomization

  6. Primaquine tolerability

    Drug tolerability between the treatment arms will also be assessed by comparing the proportion of patients completing a full course of primaquine therapy

    Measured: 7 to 14 days after randomization

  7. Pharmacogenetics CYP2D6

    Characterize hepatic cytochrome CYP2D6 enzyme phenotypes using Activity Score A (AS-A)

    Measured: 1 day after randomization

  8. Genotype CYP2D6

    Genotype CYP2D6 alleles in this study population

    Measured: 1 day after randomization

  9. Metabolomics

    Describe the metabolic signatures present in patients with adverse events (AEs) and severe AEs (SAEs)

    Measured: 28 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2021
  2. Study start26 Aug 2021
  3. Primary completion29 Jul 2024
  4. Study completion7 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05044637
Sponsor's protocol ID
CAAE: 50193921.6.1001.0005
Acronym
CHILDPRIM
Status last verified
Feb 2025
First submitted
20 Aug 2021
Last updated
20 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Pacheco ALO, Omena AG, Baia-da-Silva DC, Jardim TAP, Silva DCB, Lopes APB, Barbosa LRA, Souza IG, Araujo RF, Nogueira LOS, Vale SCN, Melo GC, Cordeiro JSM, Bassat Q, Sampaio VS, Lima VDS, Martinez-Espinosa FE, Mourao MPG, Monteiro WM, Alecrim MGC, Brito-Sousa JD, Lacerda MVG. 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 controlled trial (CHILDPRIM). Malar J. 2025 Dec 22;25(1):58. doi: 10.1186/s12936-025-05686-y.

    PubMed 41430686

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Primaquine in people with Malaria, Vivax, run by Fundação de Medicina Tropical Dr. Heitor Vieira Dourado at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Adverse Event (time frame: 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05044637, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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