Pharmacokinetic properties of single-Dose primaquine in papua new guinean children: Feasibility of abbreviated high-dose regimens for radical cure of vivax malaria

Antimicrobial Agents and Chemotherapy

Volumn 58, Issue 1, 2014, Pages 432-439

  Moore, Brioni R ^a,b   Salman, Sam ^a   Benjamin, John ^b   Page Sharp, Madhu ^c   Robinson, Leanne J ^b,d   Waita, Elizabeth ^b   Batty, Kevin T ^c   Siba, Peter ^b   Mueller, Ivo ^d,e   Davis, Timothy M E ^a   Betuela, Inoni ^b  

^a UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^b PAPUA NEW GUINEA INSTITUTE OF MEDICAL RESEARCH   (Papua New Guinea)

^c CURTIN UNIVERSITY   (Australia)

^d WALTER AND ELIZA HALL INSTITUTE OF MEDICAL RESEARCH   (Australia)

^e CENTRE FOR RESEARCH IN ENVIRONMENTAL EPIDEMIOLOGY CREAL   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

4 (6 METHOXY 8 QUINOLYLAMINO)VALERIC ACID; ANTIMALARIAL AGENT; HEMOGLOBIN; METHEMOGLOBIN; PRIMAQUINE; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ANTIMALARIAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CHILD; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG MONITORING; DRUG SAFETY; DRUG TOLERABILITY; FEASIBILITY STUDY; FEMALE; FOLLOW UP; GLUCOSE 6 PHOSPHATE DEHYDROGENASE DEFICIENCY; HEMOGLOBIN BLOOD LEVEL; HEMOGLOBIN DETERMINATION; HUMAN; LIMIT OF QUANTITATION; MALE; MASS FRAGMENTOGRAPHY; MAXIMUM PLASMA CONCENTRATION; MEDICATION COMPLIANCE; NAUSEA; PAPUA NEW GUINEA; PLASMODIUM VIVAX MALARIA; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TREATMENT DURATION; UNSPECIFIED SIDE EFFECT;

ANTIMALARIALS; CHILD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALARIA, VIVAX; MALE; PRIMAQUINE;

EID: 84891547763     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.01437-13     Document Type: Article

References (45)

1. Bhatia SC, Saraph YS, Revankar SN, Doshi KJ, Bharucha ED, Desai ND, Vaidya AB, Subrahmanyam D, Gupta KC, Satoskar RS. 1986. Pharmacokinetics of primaquine in patients with P. vivax malaria. Eur. J. Clin. Pharmacol. 31:205-210. http://dx.doi.org/10.1007/BF00606660
2. Baird JK, Hoffman S. 2004. Primaquine therapy for malaria. Clin. Infect. Dis. 39:1336-1345. http://dx.doi.org/10.1086/424663
3. Kim Y-R, Kuh H-J, Kim M-Y, Kim Y-S, Chung W-C, Kim S-I, Kang M-W. 2004. Pharmacokinetics of primaquine and carboxyprimaquine in Korean patients with vivax malaria. Arch. Pharm. Res. 27:576-580. http://dx.doi.org/10.1007/ BF02980134
4. Fernando D, Rodrigo C, Rajapakse S. 2011. Primaquine in vivax malaria: An update and review on management issues. Malar. J. 10:351. http://dx .doi.org/10.1186/1475-2875-10-351
5. Mueller I, Galinski MR, Baird JK, Carlton JM, Kochar DK, Alonso PL, del Portillo HA. 2009. Key gaps in the knowledge of Plasmodium vivax, a neglected human malaria parasite. Lancet Infect. Dis. 9:555-566. http://dx .doi.org/10.1016/S1473-3099(09)70177-X
6. Hill DR, Baird JK, Parise ME, Lewis LS, Ryan ET, Magill AJ. 2006. Primaquine: report from CDC expert meeting on malaria chemoprophylaxis I. Am. J. Trop. Med. Hyg. 75:402-415
7. Kazura JW, Siba PM, Betuela I, Mueller I. 2012. Research challenges and gaps in malaria knowledge in Papua New Guinea. Acta Trop. 121:274- 280. http://dx.doi.org/10.1016/j.actatropica.2011.08.002
8. Müller I, Bockarie M, Alpers M, Smith T. 2003. The epidemiology of malaria in PapuaNewGuinea. Trends Parasitol. 19:253-259. http://dx.doi.org/10. 1016/S1471-4922(03)00091-6
9. Poespoprodjo JR, Fobia W, Kenangalem E, Lampah DA, Hasanuddin A, Warikar N, Sugiarto P, Tjitra E, Anstey NM, Price RN. 2009. Vivax malaria: A major cause of morbidity in early infancy. Clin. Infect. Dis. 48:1704-1712. http://dx.doi.org/10.1086/599041
10. Mendis K, Sina BJ, Marchesini P, Carter R. 2001. The neglected burden of Plasmodium vivax malaria. Am. J. Trop. Med. Hyg. 64:97-106
11. Barnadas C, Koepfli C, Karunajeewa HA, Siba PM, Davis TME, Mueller I. 2011. Characterization of treatment failure in efficacy trials of drugs against Plasmodium vivax by genotyping neutral and drug resistantassociated markers. Antimicrob. Agents Chemother. 55:4479-4481. http://dx.doi.org/10.1128/AAC.01552- 10
12. Betuela I, Bassat Q, Kiniboro B, Robinson LJ, Rosanas-Urgell A, Stanisic D, Siba PM. 2012. Tolerability and safety of primaquine in Papua New Guinean children 1 to 10 years of age. Antimicrob. Agents Chemother. 56:2146-2149. http://dx.doi.org/10.1128/AAC.05566-11
13. Bartelink IH, Rademaker CM, Schobben AF, van den Anker JN. 2006. Guidelines on paediatric dosing on the basis of developmental physiology and pharmacokinetic considerations. Clin. Pharmacokinet. 45:1077- 1097. http://dx.doi.org/10.2165/00003088-200645110-00003
14. Tod M, Jullien V, Pons G. 2008. Facilitation of drug evaluation in children by population methods and modelling. Clin. Pharmacokinet. 47:231-243. http://dx.doi.org/10.2165/00003088-200847040-00002
15. John GK, Douglas NM, Von Seidlein L, Nosten F, Baird JK, White NJ, Price RN. 2012. Primaquine radical cure of Plasmodium vivax: A critical review of literature. Malar. J. 11:280. http://dx.doi.org/10.1186/1475-2875 -11-280
16. Manning L, Laman M, Townsend M-A, Chubb SP, Siba PM, Mueller I, Davis TME. 2011. Reference intervals for common laboratory tests in Melanesian children. Am. J. Trop. Med. Hyg. 85:50-54. http://dx.doi.org/10.4269/ajtmh.2011. 11-0095
17. Karunajeewa HA, Mueller I, Senn M, Lin E, Law I, Gomorrai PS, Oa O, Griffin S, Kotab K, Suano P, Tarongka N, Ura A, Lautu D, Page-Sharp M, Wong R, Salman S, Siba P, Ilett KF, Davis TME. 2008. A trial of combination antimalarial therapies in children from Papua New Guinea. N. Engl. J. Med. 359:2545-2557. http://dx.doi.org/10.1056/NEJMoa0804915
18. Page-Sharp M, Ilett KF, Betuela I, Davis TME, Batty KT. 2012. Simultaneous determination of primaquine and carboxyprimaquine in plasma using solid phase extraction and LC-MS assay. J. Chromatogr. B 902:142- 146. http://dx.doi.org/10.1016/j.jchromb.2012.06.019
19. Anderson BJ, Holford NH. 2009. Mechanistic basis of using body size and maturation to predict clearance in humans. Drug Metab. Pharmacokinet. 24:25-36. http://dx.doi.org/10.2133/dmpk.24.25
20. World Health Organization. 2009. WHO child growth standards and the identification of severe acute malnutrition in infants and children. World Health Organization, Geneva, Switzerland
21. Ebringer A, Heathcote G, Baker J, Waller M, Shanks GD, Edstein MD. 2011. Evaluation of the safety and tolerability of a short higher-dose primaquine regimen for presumptive anti-relapse therapy in healthy subjects. Trans. R. Soc. Trop. Med. Hyg. 105:568-573. http://dx.doi.org/10.1016/j.trstmh.2011.07.001
22. Pukrittayakamee S, Imwong M, Chotivanich K, Singhasivanon P, Day NP, White NJ. 2010. A comparison of two short-course primaquine regimens for the treatment and radical cure of Plasmodium vivax malaria in Thailand. Am. J. Trop. Med. Hyg. 82:542-547. http://dx.doi.org/10 .4269/ajtmh.2010.09-0428
23. Krudsood S, Tangpukdee N, Wilairatana P, Phophak N, Baird JK, Brittenham GM, Looareesuwan S. 2008. High-dose primaquine regimens against relapse of Plasmodium vivax malaria. Am. J. Trop. Med. Hyg. 78:736-740
24. Cooper WC, Myatt AV, Hernandez T, Jeffery GM, Coatney GR. 1953. Studies in human malaria. XXXI. Comparison of primaquine, isopentaquine, SN-3883, and pamaquine as curative agents against Chesson strain vivax malaria. Am. J. Trop. Med. Hyg. 2:949-957
25. Kim S, Nguon C, Guillard B, Duong S, Chy S, Sum S, Nhem S, Bouchier C, Tichit M, Christophel E, Taylor WR, Baird JK, Menard D. 2011. Performance of the CareStart G6PD deficiency screening test, a point-ofcare diagnostic for primaquine therapy screening. PLoS One 6:e28357. http://dx.doi.org/10.1371/ journal.pone.0028357
26. Tinley KE, Loughlin AM, Jepson A, Barnett ED. 2010. Evaluation of a rapid qualitative enzyme chromatographic test for glucose-6-phosphate dehydrogenase deficiency. Am. J. Trop. Med. Hyg. 82:210-214. http://dx .doi.org/10.4269/ajtmh. 2010.09-0416
27. Leslie T, Rab MA, Ahmadzai H, Durrani N, Fayaz M, Kolaczinski J, Rowland M. 2004. Compliance with 14-day primaquine therapy for radical cure of vivax malaria-a randomized placebo-controlled trial comparing unsupervised with supervised treatment. Trans. R. Soc. Trop. Med. Hyg. 98:168-173. http://dx.doi.org/10.1016/S0035-9203(03)00041-5
28. Pereira EA, Ishikawa EA, Fontes CJ. 2011. Adherence to Plasmodium vivax malaria treatment in the Brazilian Amazon region. Malar. J. 10:355. http://dx.doi.org/10.1186/1475-2875-10-355
29. Clyde DF, McCarthy VC. 1977. Radical cure of Chesson strain vivax malaria in man by 7, not 14, days of treatment with primaquine. Am. J. Trop. Med. Hyg. 26:562-563
30. Schmidt LH, Fradkin R, Vaughan D, Rasco J. 1977. Radical cure of infections with Plasmodium cynomolgi: A function of total 8-aminoquinoline dose. Am. J. Trop. Med. Hyg. 26:1116-1128
31. Clyde DF. 1981. Clinical problems associated with the use of primaquine as a tissue schizonticidal and gametocytocidal drug. Bull. World Health Organ. 59:391-395
32. Baird JK, Fryauff DJ, Hoffman SL. 2003. Primaquine for prevention of malaria in travelers. Clin. Infect. Dis. 37:1659-1667. http://dx.doi.org/10 .1086/379714
33. Ward SA, Mihaly GW, Edwards G, Looareesuwan S, Phillips RE, Chanthavanich P, Warrell DA, Orme ML, Breckenridge AM. 1985. Pharmacokinetics of primaquine in man. II. Comparison of acute vs chronic dosage in Thai subjects. Br. J. Clin. Pharmacol. 19:751-755
34. Edstein MD. 2010. Primaquine, p 2049-2058. In Grayson ML (ed), Kucers' the use of antibiotics, 6th ed, vol 2. Hodder Arnold/ASM Press, Washington, DC
35. Mihaly GW, Ward SA, Edwards G, Nicholl DD, Orme ML, Breckenridge AM. 1985. Pharmacokinetics of primaquine in man. 1. Studies of the absolute bioavailability and effects of dose size. Br. J. Clin. Pharmacol. 19:745-750
36. Edwards G, McGrath CS, Ward SA, Supanaranond W, Pukrittayakamee S, Davis TM, White NJ. 1993. Interactions among primaquine, malaria infection and other antimalarials in Thai subjects. Br. J. Clin. Pharmacol. 35:193- 198. http://dx.doi.org/10.1111/j.1365-2125.1993.tb05685.x
37. Clayman CB, Arnold J, Hockwald RS, Yount EH, Jr, Edgcomb JH, Alving AS. 1952. Toxicity of primaquine in Caucasians. JAMA 149:1563- 1568. http://dx.doi.org/10.1001/jama.1952.72930340022010b
38. Mihaly GW, Ward SA, Edwards G, Orme ML, Breckenridge AM. 1984. Pharmacokinetics of primaquine in man: identification of the carboxylic acid derivative as a major plasma metabolite. Br. J. Clin. Pharmacol. 17: 441-446. http://dx.doi.org/10.1111/j.1365-2125.1984.tb02369.x
39. Bates MD, Meshnick SR, Sigler CI, Leland P, Hollingdale MR. 1990. In vitro effects of primaquine and primaquine metabolites on exoerythrocytic stages of Plasmodium berghei. Am. J. Trop. Med. Hyg. 42:532-537
40. Link CM, Theoharides AD, Anders JC, Chung H, Canfield CJ. 1985. Structure-activity relationships of putative primaquine metabolites causing methemoglobin formation in canine hemolysates. Toxicol. Appl. Pharmacol. 81:192-202. http://dx.doi.org/10.1016/0041-008X(85)90155-3
41. Nanayakkara NP, Ager AL, Jr, Bartlett MS, Yardley V, Croft SL, Khan IA, McChesney JD, Walker LA. 2008. Antiparasitic activities and toxicities of individual enantiomers of the 8-aminoquinoline 8-[(4-amino-1- methylbutyl)amino]-6-methoxy-4-methyl-5-[3,4-dichlorophenoxy] quinoline succinate. Antimicrob. Agents Chemother. 52:2130-2137. http://dx.doi.org/10. 1128/AAC.00645-07
42. Binh VQ, Chinh NT, Thanh NX, Cuong BT, Quang NN, Dai B, Travers T, Edstein MD. 2009. Sex affects the steady-state pharmacokinetics of primaquine but not doxycycline in healthy subjects. Am. J. Trop. Med. Hyg. 81:747-753. http://dx.doi.org/10.4269/ajtmh.2009.09-0214
43. Shekalaghe SA, ter Braak R, Daou M, Kavishe R, van den Bijllaardt W, van den Bosch S, Koenderink JB, Luty AJ, Whitty CJ, Drakeley C, Sauerwein RW, Bousema T. 2010. In Tanzania, hemolysis after a single dose of primaquine coadministered with an artemisinin is not restricted to glucose-6-phosphate dehydrogenase-deficient (G6PD A-) individuals. Antimicrob. Agents Chemother. 54:1762-1768. http://dx.doi.org/10.1128/AAC.01135-09
44. World Health Organization. 2010. Guidelines for the treatment of malaria, 2nd ed. World Health Organization, Geneva, Switzerland.
45. Manning L, Laman M, Law I, Bona C, Aipit S, Teine D, Warrell J, Rosanas-Urgell A, Lin E, Kiniboro B, Vince J, Hwaiwhanje I, Karunajeewa H, Michon P, Siba P, Mueller I, Davis TM. 2011. Features and prognosis of severe malaria caused by Plasmodium falciparum, Plasmodium vivax and mixed Plasmodium species in Papua New Guinean children. PLoS One 6:e29203. http://dx.doi.org/10. 1371/journal.pone .0029203