Safety of different doses of the antimalarial drug Primaquine on Vivax Malaria Treatment in patients Deficient of the enzyme Glucose-6-phospate Dehydrogenase

Safety and efficacy of different regimens of Primaquine on Vivax Malaria treatment in Glucose-6-phospate Dehydrogenase Deficient patients admitted at the Fundação De Medicina Tropical Doutor Heitor Vieira Dourado, Manaus, Amazonas

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-2rcm2g

Enrollment

Unknown

Registered

2018-02-07

Start date

2018-07-18

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia due to glucose-6-phospate dehydrogenase deficiency

Interventions

A total of 60 patients will be recruited. The intervention group will comprise patients with uncomplicated vivax malaria and enzymatic G6PD deficiency. It will be randomized into three subgroups of 10

Group II: 10 patients who will receive a delayed seven-day course of primaquine at the dose of 0.5 mg/kilogram/day, starting only after the fifth day of the first dose of chloroquine

Group III: 10 patients who will receive the prophylactic regimen of 12 weeks of only chloroquine (5mg/kilogram/week) besides the three initial days of chloroquine. The latter group will be the control

Drug

Q65.020

Eligibility

Age

6 Months to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Male and female patients; older than 6 months of age; diagnosed with uncomplicated vivax malaria; with enzymatic activity between 10-60%

Exclusion criteria

Exclusion criteria: Exclusion criteria: Patients with severe malaria; hemoglobin levels below 9 g/dL; pregnant or breastfeeding females; children less than 6 months old; with severe enzymatic deficiency (enzymatic activity less than 10%); nephropathy; hepatopathy; under the use of potentially hemolytic drugs specified in the project; under the use of antimalarial drugs until two weeks before the study

Design outcomes

Primary

Measure	Time frame
Expected endpoint 1: End of intervention without severe adverse reactions verified by hematological and biochemical clinical and laboratory exams, defined as hemoglobin drop greater than or equal to 30% or greater than 3 g/dL of the baseline value; hemoglobin values less than 6 g/dL; alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN) and bilirubin greater than or equal to 2 times the normal maximum value; ALT greater than or equal to 8 times the ULN; ALT greater than or equal to 5 times the ULN and less than 8 times the ULN, persistent for more than or equal to 2 weeks; ALT greater than or equal to 3 times ULN plus symptoms of hepatitis or hypersensitivity; ALT greater than or equal to 5 times the ULN or less than 8 times the ULN that can not be monitored for more than two weeks; acute renal failure.	—

Measure

Time frame

Expected endpoint 1: End of intervention without severe adverse reactions verified by hematological and biochemical clinical and laboratory exams, defined as hemoglobin drop greater than or equal to 30% or greater than 3 g/dL of the baseline value; hemoglobin values less than 6 g/dL; alanine aminotransferase (ALT) greater than or equal to 3 times the upper limit of normal (ULN) and bilirubin greater than or equal to 2 times the normal maximum value; ALT greater than or equal to 8 times the ULN; ALT greater than or equal to 5 times the ULN and less than 8 times the ULN, persistent for more than or equal to 2 weeks; ALT greater than or equal to 3 times ULN plus symptoms of hepatitis or hypersensitivity; ALT greater than or equal to 5 times the ULN or less than 8 times the ULN that can not be monitored for more than two weeks; acute renal failure.

—

Secondary

Measure	Time frame
Secondary endpoint 1: Drug efficacy as defined by the presence or absence of parasites in the circulation diagnosed by thick blood smears under light microscopy (treatment failure).;Secondary endpoint 2: Variation of hemoglobin levels, measured by whole blood counts and portable device (Hemocue) before, during and after the intervention.;Secondary endpoint 3: Presence of clinical adverse reactions as a result of intervention, measured by clinical and laboratory tests, before, during and after the intervention	—

Measure

Time frame

Secondary endpoint 1: Drug efficacy as defined by the presence or absence of parasites in the circulation diagnosed by thick blood smears under light microscopy (treatment failure).;Secondary endpoint 2: Variation of hemoglobin levels, measured by whole blood counts and portable device (Hemocue) before, during and after the intervention.;Secondary endpoint 3: Presence of clinical adverse reactions as a result of intervention, measured by clinical and laboratory tests, before, during and after the intervention

—

Countries

Brazil

Contacts

Public ContactWuelton Monteiro

Fundação de Medicina Tropical Heitor Vieira Dourado - FMTHVD

wueltonmm@gmail.com+55 92 991652486

Outcome results

None listed

Source: REBEC (via WHO ICTRP)