Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children
Objectives: To assess the pharmacokinetics, safety, and tolerability of two high-dose, short-course primaquine (PQ) regimens compared with standard care in children with Plasmodium vivax infections. Methods: We performed an open-label pediatric dose-escalation study in Madang, Papua New Guinea (Clin...
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| Materiálatiipa: | Artihkal |
| Giella: | English |
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Elsevier
2023-09-01
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| Ráidu: | International Journal of Infectious Diseases |
| Fáttát: | |
| Liŋkkat: | http://www.sciencedirect.com/science/article/pii/S1201971223005714 |
| _version_ | 1827875772431335424 |
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| author | Brioni R. Moore Sam Salman Roselyn Tobe John Benjamin Gumul Yadi Bernadine Kasian Moses Laman Leanne J. Robinson Madhu Page-Sharp Inoni Betuela Kevin T. Batty Laurens Manning Ivo Mueller Timothy M.E. Davis |
| author_facet | Brioni R. Moore Sam Salman Roselyn Tobe John Benjamin Gumul Yadi Bernadine Kasian Moses Laman Leanne J. Robinson Madhu Page-Sharp Inoni Betuela Kevin T. Batty Laurens Manning Ivo Mueller Timothy M.E. Davis |
| author_sort | Brioni R. Moore |
| collection | DOAJ |
| description | Objectives: To assess the pharmacokinetics, safety, and tolerability of two high-dose, short-course primaquine (PQ) regimens compared with standard care in children with Plasmodium vivax infections. Methods: We performed an open-label pediatric dose-escalation study in Madang, Papua New Guinea (Clinicaltrials.gov NCT02364583). Children aged 5-10 years with confirmed blood-stage vivax malaria and normal glucose-6-phosphate dehydrogenase activity were allocated to one of three PQ treatment regimens in a stepwise design (group A: 0.5 mg/kg once daily for 14 days, group B: 1 mg/kg once daily for 7 days, and group C: 1 mg/kg twice daily for 3.5-days). The study assessments were completed at each treatment time point and fortnightly for 2 months after PQ administration. Results: Between August 2013 and May 2018, 707 children were screened and 73 met the eligibility criteria (15, 40, and 16 allocated to groups A, B, and C, respectively). All children completed the study procedures. The three regimens were safe and generally well tolerated. The pharmacokinetic analysis indicated that an additional weight adjustment of the conventionally recommended milligram per kilogram PQ doses is not necessary to ensure the therapeutic plasma concentrations in pediatric patients. Conclusions: A novel, ultra-short 3.5-day PQ regimen has potential benefits for improving the treatment outcomes in children with vivax malaria that warrants further investigation in a large-scale clinical trial. |
| first_indexed | 2024-03-12T17:12:45Z |
| format | Article |
| id | doaj.art-d156c12dde654c24a7b9b78d51a2d0cb |
| institution | Directory Open Access Journal |
| issn | 1201-9712 |
| language | English |
| last_indexed | 2024-03-12T17:12:45Z |
| publishDate | 2023-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | International Journal of Infectious Diseases |
| spelling | doaj.art-d156c12dde654c24a7b9b78d51a2d0cb2023-08-06T04:36:41ZengElsevierInternational Journal of Infectious Diseases1201-97122023-09-01134114122Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in childrenBrioni R. Moore0Sam Salman1Roselyn Tobe2John Benjamin3Gumul Yadi4Bernadine Kasian5Moses Laman6Leanne J. Robinson7Madhu Page-Sharp8Inoni Betuela9Kevin T. Batty10Laurens Manning11Ivo Mueller12Timothy M.E. Davis13Curtin Medical School, Curtin University, Perth, Australia; Curtin Health Innovation Research Institute, Curtin University, Perth, Australia; Medical School, The University of Western Australia, Perth, Australia; Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, Australia; Corresponding author: Tel: +618 92662956.Medical School, The University of Western Australia, Perth, Australia; Clinical Pharmacology and Toxicology Unit, PathWest, Perth, AustraliaVector Borne Disease Unit, Papua New Guinea Institute of Medical Research, Madang, Papua New GuineaVector Borne Disease Unit, Papua New Guinea Institute of Medical Research, Madang, Papua New GuineaVector Borne Disease Unit, Papua New Guinea Institute of Medical Research, Madang, Papua New GuineaVector Borne Disease Unit, Papua New Guinea Institute of Medical Research, Madang, Papua New GuineaVector Borne Disease Unit, Papua New Guinea Institute of Medical Research, Madang, Papua New GuineaPopulation Health and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia; Department of Medical Biology, University of Melbourne, Melbourne, Australia; Burnet Institute, Melbourne, AustraliaCurtin Medical School, Curtin University, Perth, AustraliaVector Borne Disease Unit, Papua New Guinea Institute of Medical Research, Madang, Papua New GuineaCurtin Medical School, Curtin University, Perth, Australia; Curtin Health Innovation Research Institute, Curtin University, Perth, AustraliaMedical School, The University of Western Australia, Perth, Australia; Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute, Perth, AustraliaDepartment of Medical Biology, University of Melbourne, Melbourne, Australia; Burnet Institute, Melbourne, AustraliaMedical School, The University of Western Australia, Perth, AustraliaObjectives: To assess the pharmacokinetics, safety, and tolerability of two high-dose, short-course primaquine (PQ) regimens compared with standard care in children with Plasmodium vivax infections. Methods: We performed an open-label pediatric dose-escalation study in Madang, Papua New Guinea (Clinicaltrials.gov NCT02364583). Children aged 5-10 years with confirmed blood-stage vivax malaria and normal glucose-6-phosphate dehydrogenase activity were allocated to one of three PQ treatment regimens in a stepwise design (group A: 0.5 mg/kg once daily for 14 days, group B: 1 mg/kg once daily for 7 days, and group C: 1 mg/kg twice daily for 3.5-days). The study assessments were completed at each treatment time point and fortnightly for 2 months after PQ administration. Results: Between August 2013 and May 2018, 707 children were screened and 73 met the eligibility criteria (15, 40, and 16 allocated to groups A, B, and C, respectively). All children completed the study procedures. The three regimens were safe and generally well tolerated. The pharmacokinetic analysis indicated that an additional weight adjustment of the conventionally recommended milligram per kilogram PQ doses is not necessary to ensure the therapeutic plasma concentrations in pediatric patients. Conclusions: A novel, ultra-short 3.5-day PQ regimen has potential benefits for improving the treatment outcomes in children with vivax malaria that warrants further investigation in a large-scale clinical trial.http://www.sciencedirect.com/science/article/pii/S1201971223005714PrimaquineVivax malariaChildrenPharmacokineticsSafetyShort-course regimen |
| spellingShingle | Brioni R. Moore Sam Salman Roselyn Tobe John Benjamin Gumul Yadi Bernadine Kasian Moses Laman Leanne J. Robinson Madhu Page-Sharp Inoni Betuela Kevin T. Batty Laurens Manning Ivo Mueller Timothy M.E. Davis Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children International Journal of Infectious Diseases Primaquine Vivax malaria Children Pharmacokinetics Safety Short-course regimen |
| title | Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children |
| title_full | Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children |
| title_fullStr | Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children |
| title_full_unstemmed | Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children |
| title_short | Short-course, high-dose primaquine regimens for the treatment of liver-stage vivax malaria in children |
| title_sort | short course high dose primaquine regimens for the treatment of liver stage vivax malaria in children |
| topic | Primaquine Vivax malaria Children Pharmacokinetics Safety Short-course regimen |
| url | http://www.sciencedirect.com/science/article/pii/S1201971223005714 |
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