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Assessing a Risk Model for G6PD Deficiency

NCT03337152 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-11-12

Study results available
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Summary

A clinical study designed to develop and inform an individual risk of hemolysis model based on individual red blood cell G6PD levels. Volunteers who are eligible to treatment with primaquine as per national guidelines and with confirmed normal G6PD levels as per the fluorescent spot test will be exposed to treatment regimens of either primaquine alone for 14 days or 3 day chloroquine with concomitant primaquine for 14 days. The volunteers will be followed intensively during treatment and for 14 days after treatment for haematologic measures, G6PD quantification, and drug level assays.

Conditions

  • Malaria, Vivax
  • G6PD Deficiency

Interventions

DRUG

primaquine

Participants receive primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.

DRUG

chloroquine + primaquine

Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • PATH

    lead OTHER

Principal Investigators

  • François Nosten, MD, PhD · Shoklo Malaria Research Unit (SMRU), Mahidol-Oxford Tropical Medicine Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2018-08-21
Completion
2018-10-21

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03337152 on ClinicalTrials.gov