Validation of New G6PD Point of Care Tests Against Gold Standard Quantitative

NCT ID: NCT02625285

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-24
• Study Completion Date: 2018-01-31

Brief Summary

This is a laboratory research to evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping.

Detailed Description

Radical cure of P. vivax malaria can be achieved using large doses of primaquine which have shown to cause some degree of hemolysis even in subjects who tested normal by the conventional qualitative G6PD tests. Different regimens of drug might be more appropriate in subjects with intermediate G6PD activity which can be currently measured only in well equipped laboratories. Validation of new qualitative and quantitative point-of-care tests is essential to for safe deployment of standard and new radical cure regimens against Plasmodium vivax.

This study will evaluate performances of quantitative POC G6PD tests (Biosensors) against gold standard quantitative laboratory based tests and genotyping. Patients will be searched from the electronic record database to identify up to 150 patients with the following characteristics: approximately 50 G6PD-deficient men and women (however only a very small percent of deficients are homozygous women) approximately 50 G6PD-heterozygous women with intermediate activity, and approximately 50 G6PD-normal individuals and patients who meet the screening criteria will be contacted at their home by a clinic staff member. The home visitor will explain study details and invite to participate in the study. If the patients express interest in participating, they will be directed to visit the following month at the clinic where they usually receive care.

After signing the informed consent form, two blood samples will be withdrawn; one sample will be taken by finger-stick (200 µl) and one sample (0.5 ml) will be taken by arm venipuncture. The blood from capillary sample will be used to assess G6PD activity using the POC tests, CBC and laboratory based quantitative tests. The venous blood will be used for reference standard quantitative G6PD assays, Hb typing analysis, CBC and buffy-coat will be stored for DNA extraction for G6PD genotyping only; leftover blood will be discarded.

Conditions

Validation; Biosensors; Genotyping

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

G6PD Deficient Volunteers

• Subjects with age ≥ 18 years
• Male and female
• Previously tested G6PD deficient at SMRU clinic

No interventions assigned to this group

G6PD Intermediate or Heterozygous Volunteers

• Subjects with age ≥ 18 years
• Female
• Previously tested G6PD intermediate or heterozygous for G6PD variants at SMRU clinic

No interventions assigned to this group

G6PD-Normal Volunteers

• Subjects with age ≥ 18 years
• Male and female
• Previously tested G6PD normal at SMRU clinic

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Subjects with age ≥ 18 years
• Subjects willing to participate and sign informed consent form
• Male and Female
• Previously tested G6PD deficient, G6PD normal and G6PD intermediate or heterozygous for G6PD variants at SMRU clinic

Exclusion Criteria

• Patients with severe malaria or other severe or any acute illness
• Patients who received a blood transfusion in the last 3 months
• Patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)
• Patients who have not had a critical illness or received other hemolytic drugs (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

PATH

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shoklo Malaria Research Unit,

Mae Sot, Changwat Tak, Thailand

Countries

Thailand

Other Identifiers

SMRU1501

Identifier Type: -

Identifier Source: org_study_id