Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure With Tafenoquine or Primaquine After Quantitative G6PD Testing in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- Appropriate use of TQ based on G6PD activity
研究概览
简要总结
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.
详细描述
This is a prospective, observational, multi-center, longitudinal study to be conducted in Yala province and Mae Hong Son province in patients with P. vivax malaria.
Since 2020, quantitative G6PD testing has been available for routine use prior to providing PQ radical therapy at district hospitals and malaria clinics in the study provinces, in line with the national guidelines.
Before study start, the relevant staff at all participating sites will be re-trained on the quantitative G6PD test procedure and the radical cure treatment algorithm by the Division of Vector Borne Diseases (DVBD). Standard operating procedures (SOP) for identification of patients with suspected AHA and guidance for initial management and transfer to a referral hospital will be provided.
G6PD tests and TQ will be supplied to Health Facilities (HFs) by the DVBD using the usual supply route for drugs and diagnostics. PQ and other anti-malarial drugs are already available in Thailand.
Within the study period, investigators will prospectively enroll all patients meeting the selection criteria.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Tafenoquine (Drug)
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.
干预措施: Primaquine (Drug)
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.
干预措施: Primaquine (Drug)
结局指标
主要结局
Appropriate use of TQ based on G6PD activity
时间窗: 8 months
Percentage of P. vivax patients aged ≥16 years treated or not with TQ in accordance with the appropriate level of G6PD enzyme activity
次要结局
- Appropriate use of PQ based on G6PD activity(8 months)
- Appropriate application of treatment algorithm(8 months)
- Reported drug-induced AHA.(8 months)
研究者
Dr. Prayuth Sudathip
Deputy Director, DVBD
Ministry of Health, Thailand