G6PD Assessment Before Primaquine for Radical Treatment of Vivax Malaria
Status:
Completed
Trial end date:
2018-11-01
Target enrollment:
Participant gender:
Summary
This will be a single-arm observational cohort study. Malaria patients with Plasmodium vivax
and meeting study inclusion criteria, who give consent to be enrolled in the study, will have
their G6PD status measured by the CareStart™ G6DP rapid diagnostic test (G6PD RDT), and
primaquine prescribed according to the result. According to the G6PD RDT result, primaquine
will be prescribed at 0.25mg/kg/day for 14 days (normal patients) or 0.75mg/kg weekly for
eight weeks (deficient patients). All will receive treatment with chloroquine to clear
asexual stages of infection.
Patients will be reviewed at day 2, day 7 and day 14. At these visits patients will undergo a
brief clinical assessment and a small blood sample will be taken for repeat haemoglobin
measurement and dried blood spot for carboxyprimaquine measurement (day 7 and day 14 only).
In general, antimalarial treatment will be unsupervised to reflect field conditions. However
a subset of 25 G6PD normal patients at a single site will have each day of their primaquine
treatment administered and observed at the treatment centre. This is to determine a
calibration curve for primaquine pharmacokinetic studies.
Dried blood spots will be stored appropriately. Day zero samples will be genotyped in Bangkok
(MORU, Dr. Mallika Imwong) after DNA extraction. PCR-RFLP will be used to detect the allele
associated with the Mediterranean variant of G6PD deficiency. In addition DNA extracts will
be sent for more systematic genetic testing for known G6PD variants through existing
collaborations with the Wellcome Trust Sanger Institute. The day 7 and 14 dried blood spot
samples will be analysed in the MORU pharmacology laboratory for primaquine and
carboxyprimaquine concentrations, from which adherence to primaquine can be determined
retrospectively, using the subset of 25 patients receiving directly observed therapy to
calibrate the results.
Funder: WellcomeTrust, Grant reference: 107548/Z/15/Z
Phase:
Phase 4
Details
Lead Sponsor:
University of Oxford
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit Nangarhar University Nangarhar University, Afghanistan