drugset / Trial / NCT03916003
Reducing the Risk of P. Vivax After Falciparum Infections in Co-endemic Areas
Phase 4
Completed
500 enrolled
Menzies School of Health Research
Addis Ababa University · collabArba Minch University · collabInternational Centre for Diarrhoeal Disease Research, Bangladesh · collabTribhuvan University, Nepal · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed as a multi-centre randomized, open label trial to compare the safety and efficacy of a high dose primaquine (PQ) treatment in G6PD normal patients with P. falciparum to reduce the risk of subsequent P. vivax episodes to current standard practice of providing only schizontocidal treatment.
Timeline
- Start
- 2019-08-18
- Primary completion
- 2022-05-14
- Completion
- 2022-07-30
Outcome
Met primary endpoint
paper in the standard care arm compared with 2·5% (1·0-5·9) in the intervention arm (hazard ratio 0·20, 95% CI 0·08-0·51; p=0·0009). PMID 37979594 ↗
Publications
- Vernandes M, Agustine W, Fadilah I, Christian M, Rumaseb A, Subekti D, Louisa M, Price RN, Thriemer K, Baird JK. Primaquine-derived 5,6-orthoquinone concentrations in urine associated with CYP2D6 genotype-predicted phenotype and blood methemoglobin levels. Antimicrob Agents Chemother. 2026 Jul 13:e0053926. doi: 10.1128/aac.00539-26. Online ahead of print.
- Thriemer K, Degaga TS, Christian M, Alam MS, Rajasekhar M, Ley B, Hossain MS, Kibria MG, Tego TT, Abate DT, Weston S, Mnjala H, Rumaseb A, Satyagraha AW, Sadhewa A, Panggalo LV, Ekawati LL, Lee G, Anose RT, Kiros FG, Simpson JA, Karahalios A, Woyessa A, Baird JK, Sutanto I, Hailu A, Price RN. Primaquine radical cure in patients with Plasmodium falciparum malaria in areas co-endemic for P falciparum and Plasmodium vivax (PRIMA): a multicentre, open-label, superiority randomised controlled trial. Lancet. 2023 Dec 2;402(10417):2101-2110. doi: 10.1016/S0140-6736(23)01553-2. Epub 2023 Nov 15.
- Thriemer K, Degaga TS, Christian M, Alam MS, Ley B, Hossain MS, Kibria MG, Tego TT, Abate DT, Weston S, Karahalios A, Rajasekhar M, Simpson JA, Rumaseb A, Mnjala H, Lee G, Anose RT, Kidane FG, Woyessa A, Baird K, Sutanto I, Hailu A, Price RN. Reducing the risk of Plasmodium vivax after falciparum infections in co-endemic areas-a randomized controlled trial (PRIMA). Trials. 2022 May 18;23(1):416. doi: 10.1186/s13063-022-06364-z.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Primaquine | Small molecule | 1 mg/kg | Oral |