Safety of different doses of the antimalarial drug Primaquine on Vivax Malaria Treatment in patients Deficient of the enzyme Glucose-6-phospate Dehydrogenase
Phase 2
Recruiting
- Conditions
- Anemia due to glucose-6-phospate dehydrogenase deficiencymalaria by Plasmodium vivaxB51.8D55.0
- Registration Number
- RBR-2rcm2g
- Lead Sponsor
- Fundação de Medicina Tropical Heitor Vieira Dourado - FMTHVD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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