Clinical trial
Safety and Efficacy of Different Regimens of Primaquine on Vivax Malaria Treatment in Glucose 6-phosphate Dehydrogenase Deficient Patients
Name
CAAE: 70177317.1.0000.0005
Description
A clinical study to assess the safety and efficacy of alternative regimens of primaquine for radical cure of vivax malaria in glucose 6-phosphate dehydrogenase (G6PD) deficient. G6PD deficient patients with P. vivax monoinfection will be treated with either weekly or delayed one-week course of primaquine, and the currently recommended by national guideline, 12-week chloroquine regimen to compare treatment safety among groups. All groups will be actively monitored for hemolysis during treatment and will have six-month follow-up period to assess treatment efficacy.
Trial arms
Trial start
2018-07-20
Estimated PCD
2023-07-01
Trial end
2023-11-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Chloroquine
Standard chloroquine (three days)
Arms:
1a: Chloroquine + 5th-day Primaquine, 1b: Chloroquine + 8-week Primaquine, 1c: Chloroquine + 12-week Chloroquine, 2: Standard chloroquine + primaquine
Primaquine
Daily Primaquine (0.5 mg of base/kg/day for seven days) starting only at the fifth day post chloroquine initiation.
Arms:
1a: Chloroquine + 5th-day Primaquine
Primaquine
Weekly primaquine (0.75 mg of base/kg/week for eight weeks) starting with first dose of chloroquine.
Arms:
1b: Chloroquine + 8-week Primaquine
Chloroquine
Weekly, once a week chloroquine (5 mg of base/kg/week for twelve weeks)
Arms:
1c: Chloroquine + 12-week Chloroquine
Primaquine
Standard primaquine (0.5mg of base/kg/day for seven days) concomitant with chloroquine.
Arms:
2: Standard chloroquine + primaquine
Size
106
Primary endpoint
Absolute or relative change in hemoglobin < 3g/dL or 30% from baseline
From date of randomization until the date of last dose, assessed up to 12 weeks.
Eligibility criteria
Inclusion Criteria:
* Uncomplicated vivax malaria monoinfection
* G6PD deficiency ranging from 10%-60% of adjusted mean male activity
* Baseline hemoglobin \>9 g/dL
* Willing to comply with study requirements
Exclusion Criteria:
* Pregnancy or breastfeeding
* Comorbidities (hepatopathy and/or nephropathy)
* Use of antimalarials in the previous two weeks or current use of potentially hemolytic drugs
* Any condition which would place the subject at undue risk of hemolysis or interfere with the results of the study, as judged by investigator.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 106, 'type': 'ACTUAL'}}
Updated at
2023-03-29
1 organization
2 products
2 indications
Product
ChloroquineIndication
Malaria caused by Plasmodium vivaxProduct
Primaquine