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Item Metadata only Co-design of a routine clinical review to improve the safety of high dose radical cure treatment for Plasmodium vivax malaria: findings from Cambodia and Ethiopia(2025-12-01) Cassidy-Seyoum S.A.; Mwaura M.; Chheng K.; Kejela M.; Korra K.G.; Wodaj T.; Degaga T.S.; Hsiang M.S.; von Seidlein L.; Tripura R.; Adhikari B.; Ley B.; Lek D.; Price R.N.; Engel N.; Thriemer K.; Cassidy-Seyoum S.A.; Mahidol University. Collaboration has the potential to enable quality of care and patient safety. Suitable ways of reinforcing this relational infrastructure are required to optimize case management of patients.... effectiveness but can increase the risk of adverse events. A clinical review visit on day 3 post-treatment initiation could facilitate adherence and improve safety, but it is unclear how it could be integrated into routine malaria care. Methods: Between MarchItem Metadata only Safety and efficacy of primaquine in patients with Plasmodium vivax malaria from South Asia: A systematic review and individual patient data meta-analysis(2023-12-20) Verma R.; Commons R.J.; Gupta A.; Rahi M.; Nitika; Bharti P.K.; Thriemer K.; Rajasekhar M.; Singh-Phulgenda S.; Adhikari B.; Alam M.S.; Ghimire P.; Khan W.A.; Kumar R.; Leslie T.; Ley B.; Llanos-Cuentas A.; Pukrittayakamee S.; Rijal K.R.; Rowland M.; Saravu K.; Simpson J.A.; Guerin P.J.; Price R.N.; Sharma A.; Verma R.; Mahidol UniversityBackground The optimal dosing of primaquine to prevent relapsing Plasmodium vivax malaria in South Asia remains unclear. We investigated the efficacy and safety of different primaquine regimens to prevent P. vivax relapse. Methods A systematic... review identified P. vivax efficacy studies from South Asia published between 1 January 2000 and 23 August 2021. In a one-stage meta-analysis of available individual patient data, the cumulative risks of P. vivax recurrence at day 42 and 180 were assessedItem Metadata only High-dose, short-course primaquine after point-of-care G6PD testing for the radical cure of Plasmodium vivax malaria: a safety study in Papua New Guinea and Indonesia(2026-06-01) Fransisca L.; Ome-Kaius M.; Laman M.; Poespoprodjo J.R.; Pasaribu A.P.; Sutanto I.; Malai M.; Nelwan E.; Adella J.; Abegini C.; Ainur F.; Amdara Y.; Angeline S.; Brown K.; Burdam F.H.; Curry E.; Daimen M.; Daly P.; Do T.; Dori A.; Douglas N.M.; Huegel H.; Hutagalung A.P.; Jambert E.; Jimanto V.; Karo V.; Kenangalem E.; Kelebi T.; Kisomb J.; Laksono I.; Lee G.; Ley B.; Mannion K.; Plinduo J.; Pukai I.; Putri A.; Rajasekhar M.; Ronkentou S.; Rosens E.; Sakalidis V.S.; Satyagraha A.; Simpson J.A.; Theodora M.; Ubra R.; Vakore N.; Wansom T.; Duparc S.; Robinson L.J.; Price R.N.; Fransisca L.; Mahidol Universityof patients with P. vivax malaria was feasible and the primaquine regimens had acceptable safety profiles. The study paves the way for large scale implementation studies of the intervention. Funding: UNITAID and Australian National Health and Medical Research...Background: High total dose primaquine (PQ 7 mg/kg) over 7 days can improve treatment adherence and reduce Plasmodium vivax malaria recurrences. We evaluated the safety of pre-treatment glucose-6-phosphate dehydrogenase (G6PD) testing followedItem Metadata only 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(2026-01-01) Degaga T.S.; Pasaribu A.P.; Tripura R.; Ghanchi N.; Rajasekhar M.; Adhikari B.; Ley B.; Bamboro S.A.; Jabbar F.A.; Hasibuan N.; Tego T.T.; Zehra S.; Qurashi B.; Mnjala H.; Lee G.; Li P.; Kazi A.M.; Safitri W.; Yulita Y.; Siagian D.S.P.; Syahputra D.; Hadi H.; Muhammad T.; Ibrahim A.; Syed N.; Dost K.; Puspitrasari A.M.; Kariodimedjo P.P.; Rai A.; Rumaseb A.; Sutanto E.; Ean M.; Khan A.; Sokha M.; Commons R.J.; Weston S.; Noviyanti R.; Peto T.; Callery J.J.; Ali U.; Mehmood T.; Dondorp A.; Devine A.; Setiawan E.; Mwaura M.; Cassidy-Seyoum S.; Temesgen R.; Abate D.T.; Erjabo E.B.; Gessa G.G.; Kiros F.G.; Usmani M.I.; Raza A.; Woyessa A.; Hailu A.; Simpson J.A.; Karahalios A.; Beg M.A.; von Seidlein L.; Dysoley L.; Auburn S.; Price R.N.; Thriemer K.; Degaga T.S.; Mahidol Universityto assess the effectiveness and safety of these new treatment options. Methods: We conducted a multicentre, open-label, randomised, controlled, superiority trial in Ethiopia, Pakistan, Indonesia, and Cambodia. Adult patients (aged ≥18 years, or aged ≥16... years in Indonesia) with uncomplicated P vivax infection and glucose-6-phosphate dehydrogenase (G6PD) activity of 70% or greater were eligible for enrolment. Patients were treated with blood schizonticidal drugs (chloroquine in Ethiopia and PakistanItem Metadata only A randomised controlled trial to compare the efficacy, safety, and tolerability of low dose, short course primaquine in adults with uncomplicated P. vivax malaria in two hospitals in India(2024-12-01) Ahmad S.S.; Verma R.; Commons R.J.; Nitika; Singh-Phulgenda S.; Chhajed R.; Bharti P.K.; Behera B.; Naser S.M.; Pal S.K.; Ranjit P.H.; Baharia R.K.; Solanki B.; Upadhyay K.J.; Guerin P.J.; Sharma A.; Price R.N.; Rahi M.; Thriemer K.; Ahmad S.S.; Mahidol Universitywith primaquine at a dose of 0.25 mg/kg/day provided over 14 days. Shorter treatment courses may improve adherence and treatment effectiveness. Methods: This is a hospital-based, randomised, controlled, open-label trial in two centres in India. Patients above... 7-day primaquine at 0.50 mg/kg/day or standard care with schizonticidal treatment plus 14-day primaquine at 0.25 mg/kg/day. Patients will be followed up for 6 months. The primary endpoint is the incidence risk of any P. vivax parasitaemia at 6 monthsItem Metadata only Automated reporting of primaquine dose efficacy, tolerability and safety for Plasmodium vivax malaria using a systematic review and individual patient data meta-analysis(2025-11-14) Edler P.; Rajasekhar M.; Price D.J.; Adam I.; Awab G.R.; Barber B.E.; Brasil L.W.; Chamma-Siqueira N.N.; Chu C.S.; Cui L.; Daher A.; Gomes M.d.S.M.; Gonzalez-Ceron L.; Grigg M.J.; Karunajeewa H.; Lacerda M.V.G.; Ladeia-Andrade S.; Leslie T.; Ley B.; Lidia K.; Llanos-Cuentas A.; Longley R.J.; Manning L.; Mekonnen D.A.; Monteiro W.M.; Moore B.R.; Nosten F.; Pasaribu A.P.; Pereira D.B.; Poespoprodjo J.R.; Pukrittayakamee S.; Rijal K.R.; Saravu K.; Siqueira A.M.; Sutanto I.; Taylor W.R.J.; Thanh P.V.; Thriemer K.; Vieira J.L.F.; White N.J.; Yeshiwondim A.K.; Zuluaga-Idarraga L.M.; Guerin P.J.; Simpson J.A.; Price R.N.; Commons R.J.; Edler P.; Mahidol Universityof primaquine mg/kg dose on efficacy, hematological safety and gastrointestinal tolerability. RESULTS: As of January 16, 2025, a total of 9,270 individual patient data records from 41 studies have been collated into the standardized repository. Open-access... require local information on efficacy, tolerability and safety to optimize antimalarial treatment policies for Plasmodium vivax malaria control and elimination efforts. METHODS: A living systematic review identified efficacy studies of uncomplicated PItem Metadata only Safety of single-dose primaquine as a Plasmodium falciparum gametocytocide: a systematic review and meta-analysis of individual patient data(2022-12-01) Stepniewska K.; Allen E.N.; Humphreys G.S.; Poirot E.; Craig E.; Kennon K.; Yilma D.; Bousema T.; Guerin P.J.; White N.J.; Price R.N.; Raman J.; Martensson A.; Mwaiswelo R.O.; Bancone G.; Bastiaens G.J.H.; Bjorkman A.; Brown J.M.; D’Alessandro U.; Dicko A.A.; El-Sayed B.; Elzaki S.E.; Eziefula A.C.; Gonçalves B.P.; Hamid M.M.A.; Kaneko A.; Kariuki S.; Khan W.; Kwambai T.K.; Ley B.; Ngasala B.E.; Nosten F.; Okebe J.; Samuels A.M.; Smit M.R.; Stone W.J.R.; Sutanto I.; Ter Kuile F.; Tine R.C.; Tiono A.B.; Drakeley C.J.; Gosling R.; Stergachis A.; Barnes K.I.; Chen I.; Mahidol Universitydehydrogenase (G6PD) testing, to accelerate malaria elimination efforts and avoid the spread of artemisinin resistance. Uptake of this recommendation has been relatively slow primarily due to safety concerns. Methods: A systematic review and individual patient... primaquine is associated with a transient reduction in haemoglobin levels in G6PD-deficient individuals, haemoglobin levels at clinical presentation are the major determinants of anaemia in these patients. Trial registration: PROSPERO, CRD42019128185.Item Metadata only High daily dose Short COurse PrimaquinE after G6PD testing for the radical cure of Plasmodium vivax malaria in Indonesia and Papua New Guinea: the SCOPE implementation study protocol(2025-12-01) Price R.N.; Robinson L.J.; Duparc S.; Wansom T.; Jambert E.; Demarest H.; Huegel H.; Do T.; Brown K.; Simpson J.A.; Abraham P.; Devine A.; Ley B.; Lee G.; Adella J.; Sakalidis V.S.; Rahmalia A.; Curry E.; Mannion K.; Douglas N.M.; Farquhar R.; Daly P.; Rosens E.; Makita L.; Amdara Y.; Ronkentuo S.; Pukai I.; Abegini C.; Malai M.; Ome-Kaius M.; Pomat W.; Theodora M.; Satyagraha A.W.; Putri A.; Angeline S.; Hutagalung A.P.; Ainur F.; Jimanto V.; Burdam F.H.; Kenangalem E.; Fransisca L.; Nelwan E.; Sutanto I.; Pasaribu A.P.; Laman M.; Poespoprodjo J.R.; Price R.N.; Mahidol Universityon analysis of treatment safety. If safety of the intervention is confirmed during Stage 1, the study will proceed to Stage 2, in which patient recruitment will be expanded to 10 clinics across Indonesia and PNG, and the feasibility of the similar intervention.... Primaquine is the only widely available drug with antirelapse activity against dormant stages of P. vivax. Its widespread use in clinical practice is limited by its potential to cause severe haemolysis in patients with glucose-6-phosphate dehydrogenase (G6PDItem Metadata only Response to comment on 'The clinical pharmacology of tafenoquine in the radical cure of Plasmodium vivax malaria: An individual patient data meta-analysis'(2024-02-07) Watson J.A.; Commons R.J.; Tarning J.; Simpson J.A.; Llanos Cuentas A.; Lacerda M.V.G.; Green J.A.; Koh G.C.K.W.; Chu C.S.; Nosten F.H.; Price R.N.; Day N.P.J.; White N.J.; Watson J.A.; Mahidol UniversityIn our recent paper on the clinical pharmacology of tafenoquine (Watson et al., 2022), we used all available individual patient pharmacometric data from the tafenoquine pre-registration clinical efficacy trials to characterise the determinants... the risk of vivax recurrence by four months. We recommended that clinical trials of higher doses should be carried out to assess their safety and tolerability. Sharma and colleagues at the pharmaceutical company GSK defend the currently recommended adultItem Metadata only Weekly primaquine for radical cure of patients with Plasmodium vivax malaria and glucose-6-phosphate dehydrogenase deficiency(2023-09-01) Taylor W.R.J.; Meagher N.; Ley B.; Thriemer K.; Bancone G.; Satyagraha A.; Assefa A.; Chand K.; Chau N.H.; Dhorda M.; Degaga T.S.; Ekawati L.L.; Hailu A.; Hasanzai M.A.; Naddim M.N.; Pasaribu A.P.; Rahim A.G.; Sutanto I.; Thanh N.V.; Tuyet-Trinh N.T.; Waithira N.; Woyessa A.; Dondorp A.; von Seidlein L.; Simpson J.A.; White N.J.; Baird J.K.; Day N.P.; Price R.N.; Mahidol Universityand safety are limited. METHODS: Within the context of a multicentre, randomised clinical trial of two primaquine regimens in P. vivax malaria, patients with G6PD deficiency were excluded and enrolled into a separate 12-month observational study. They were...BACKGROUND: The World Health Organization recommends that primaquine should be given once weekly for 8-weeks to patients with Plasmodium vivax malaria and glucose-6-phosphate dehydrogenase (G6PD) deficiency, but data on its antirelapse efficacy
