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| Name | Class |
|---|---|
| University of Melbourne | OTHER |
| National Centre for Parasitology, Entomology and Malaria Control, Cambodia | OTHER |
| Mahidol Oxford Tropical Medicine Research Unit | OTHER |
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Health care facility based, randomized, controlled, open label, superiority trial with 3 arms
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients are treated with schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days (PQ14) | |
| PQ Intervention | Experimental | Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7) |
|
| TQ Intervention | Experimental | Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tafenoquine | Drug | patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence risk any P vivax PQ7 / PQ14 | The incidence risk (time to first event) of any P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence risk any P vivax PQ7 / TQ | The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms | 6 months |
| Incidence risk symptomatic P vivax TQ / PQ14 |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamala Thriemer, MD, MPH, PhD | Menzies School of Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kravanh District Hospital | Pursat | Pursat | Cambodia | |||
| Chambak Health Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41690325 | Derived | 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. |
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Study Protocol and Statistical Analysis Plan will be made available to others. Data collected for the study, including individual patient data and the final trial dataset are reserved for the chief investigator and co-investigators of the trial. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Trial results will be published in peer-reviewed open access journals and disseminated to trial stakeholders, including participants, as per ethical guidelines.
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The data are available for access via the WorldWide Antimalarial Resistance Network (WWARN.org). Requests for access will be reviewed by a Data Access Committee to ensure that use of data protects the interests of the participants and researchers according to the terms of ethics approval and principles of equitable data sharing. Requests can be submitted by email to malariaDAC@iddo.org via the Data Access Form available at WWARN.org/accessing-data. The WWARN is registered with the Registry of Research Data Repositories (re3data.org).
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| ID | Term |
|---|---|
| D016780 | Malaria, Vivax |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C055852 | tafenoquine |
| D011319 | Primaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Ethiopian Public Health Institute |
| OTHER_GOV |
| Universitas Sumatera Utara | OTHER |
| Arba Minch University | OTHER |
| Aga Khan University | OTHER |
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| Primaquine | Drug | patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7) |
|
|
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between TQ and the control arm (PQ14). |
| 6 months |
| Incidence risk any P vivax PQ7 / PQ14 | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14). | 6 months |
| Incidence risk any P vivax PQ7 / TQ | • The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms | 6 months |
| Incidence risk any P vivax PQ14 / TQ | The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ14 and TQ arms | 6 months |
| Kampong Speu |
| Cambodia |
| Siem Pang Health Centre | Stung Treng | Cambodia |
| Arba Minch General Hospital | Arba Minch | Ethiopia |
| Tanjung Leidong Health Center | Labuhanbatu | Sumatera | Indonesia |
| Aga Khan Hospital Karachi | Karachi | Pakistan |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D006571 | Heterocyclic Compounds |