drugset

drugset / Trial / NCT04411836

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

NCT04411836 ↗

Phase 3 Completed 960 enrolled Menzies School of Health Research Aga Khan University · collab Arba Minch University · collab Ethiopian Public Health Institute · collab Mahidol Oxford Tropical Medicine Research Unit · collab National Centre for Parasitology, Entomology and Malaria Control, Cambodia · collab Universitas Sumatera Utara · collab University of Melbourne · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

Timeline

Start: 2021-04-25
Primary completion: 2024-09-30
Completion: 2024-09-30

Outcome

Missed primary endpoint

paper hazard ratio [HR] 0·66 [97·55% CI 0·40-1·09], p=0·063). PMID 41690325 ↗

Publications

Degaga TS, Pasaribu AP, Tripura R, Ghanchi N, Rajasekhar M, Adhikari B, Ley B, Bamboro SA, Jabbar FA, Hasibuan N, Tego TT, Zehra S, Qurashi B, Mnjala H, Lee G, Li P, Kazi AM, Safitri W, Yulita Y, Siagian DSP, Syahputra D, Hadi H, Muhammad T, Ibrahim A, Syed N, Dost K, Puspitrasari AM, Kariodimedjo PP, Rai A, Rumaseb A, Sutanto E, Ean M, Khan A, Sokha M, Commons RJ, Weston S, Noviyanti R, Peto T, Callery JJ, Ali U, Mehmood T, Dondorp A, Devine A, Setiawan E, Mwaura M, Cassidy-Seyoum S, Temesgen R, Abate DT, Erjabo EB, Gessa GG, Kiros FG, Usmani MI, Raza A, Woyessa A, Hailu A, Simpson JA, Karahalios A, Beg MA, von Seidlein L, Dysoley L, Auburn S, Price RN, Thriemer K. Effectiveness and safety of 7-day high-dose primaquine and single-dose tafenoquine versus 14-day low-dose primaquine in patients with Plasmodium vivax malaria (EFFORT): a multicentre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis. 2026 Jun;26(6):614-626. doi: 10.1016/S1473-3099(25)00729-7. Epub 2026 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Primaquine	Small molecule	7 mg/kg	—
Subject	Tafenoquine	Small molecule	300 mg	—

Indications