Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand

NCT05753150 | Completed DMC

• 1 other identifier: MMV_TQ_18_01
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this prospective, observational study is to assess the operational feasibility of appropriate radical cure treatment for P. vivax malaria with tafenoquine or primaquine, in patients 16 year and older, after G6PD testing in Thailand. The study will be implemented in a phased manner, in the provinces of Yala and Mae Hong Son. The first phase will be at higher level health facilities (hospitals). An interim analysis will be conducted after 40 patients are enrolled in the study in order to decide whether the study could be extended to lower level HFs. If approved by the Independent Study Oversight Committee, the study will be implemented in lower level HFs (malaria clinics).Higher level HFs will continue to include patients in the study during this 2nd phase.Written informed consent / assent is required from all patients /guardians in the case of minors.

Conditions

Malaria, Vivax; G6PD Deficiency

Keywords

Tafenoquine; Primaquine; G6PD testing; Operational study; Thailand

Outcome Measures

Primary Outcomes (1)

• Appropriate use of TQ based on G6PD activity

  Percentage of P. vivax patients aged ≥16 years treated or not with TQ in accordance with the appropriate level of G6PD enzyme activity

  8 months

Secondary Outcomes (3)

• Appropriate use of PQ based on G6PD activity

  8 months

• Appropriate application of treatment algorithm

  8 months

• Reported drug-induced AHA.

  8 months

Study Arms (3)

Tafenoquine (TQ)

Patients aged ≥16 years, G6PD activity ≥ 6.1 U/gHb, not pregnant or breastfeeding, will receive single-dose TQ in addition to chloroquine, the standard blood schizonticidal drug.

Drug: Tafenoquine

Daily primaquine (PQ) for 14 days

Patients aged ≥16 years, G6PD activity ≥ 4.1 U/gHb, not pregnant or breastfeeding, will receive 14-day PQ in addition to chloroquine, the standard blood schizonticidal drug.

Drug: Primaquine

Weekly primaquine (PQ) for 8 weeks

Patients aged ≥16 years, G6PD activity ≤ 4.0 U/gHb, not pregnant or breastfeeding, will receive 14-day PQ in addition to chloroquine, the standard blood schizonticidal drug.

Drug: Primaquine

Interventions

Tafenoquine DRUG

Tafenoquine 300 mg (2x150 mg tablets)

Also known as: Kozenis

Tafenoquine (TQ)

Primaquine DRUG

Daily primaquine adjusted by weight (0.25 mg/kg/day for 14 days)

Daily primaquine (PQ) for 14 days

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study will be conducted at hospitals and malaria clinics in the provinces of Yala and Mae Hong Son in Thailand.

You may qualify if:

• Thai patient aged ≥16 years at enrolment
• Diagnosed with a mono-species, uncomplicated P. vivax malaria that is parasitologically confirmed through standardized Giemsa microscopy.
• Weighs \>35 kg
• Haemoglobin level must be \>7gm%
• Less than 24h away from emergency care

You may not qualify if:

• Participating in a clinical trial
• Diabetic patients who are (1) being treated with metformin (because of possible increase in the risk of lactic acidosis due to metformin when administered in combination with tafenoquine) (2) G6PD-deficient and being treated with sulfonylureas e.g. Glucotrol, Glynase, Metaglip and Micronase (because of the increased risk of haemolysis in this population).
• Pregnant/lactating women, women with suspected pregnancy.1
• Cases of severe/ complicated malaria

Sponsors & Collaborators

• Dr. Prayuth Sudathip: lead
• Medicines for Malaria Venture: collaborator

Study Sites (9)

District Hospital

Mae Sariang, Changwat Mae Hong Son, 58110, Thailand

Location

Malaria Clinic

Mae Sariang, Changwat Mae Hong Son, 58110, Thailand

Location

District Hospital

Sop Moei, Changwat Mae Hong Son, 58110, Thailand

Location

District Hospital

Bannang Sata, Changwat Yala, 95130, Thailand

Location

Malaria Clinic

Bannang Sata, Changwat Yala, 95130, Thailand

Location

District Hospital

Ka Bang, Changwat Yala, 95120, Thailand

Location

Malaria Clinic

Mueang, Changwat Yala, 95000, Thailand

Location

District Hospital

Than To, Changwat Yala, 95150, Thailand

Location

Malaria Clinic

Than To, Changwat Yala, 95150, Thailand

Location

MeSH Terms

Conditions

Malaria, Vivax; Glucosephosphate Dehydrogenase Deficiency

Interventions

tafenoquine; Primaquine

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chantana Padungtod, M.D., DrPH

  Director, Dept. Vector Borne Diseases (DVBD)

  PRINCIPAL INVESTIGATOR

• Saowanee Viboonsanti, M.D.

  Director, ODPC Reg. No. 1

  PRINCIPAL INVESTIGATOR

• Chalermpol Chalermpol, M.D.

  Director, ODPC Reg. No. 12

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director, DVBD

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 3, 2023
• Study Start: May 23, 2022
• Primary Completion: August 31, 2023
• Study Completion: October 1, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

TH (9)