Evaluating the pharmacodynamic effect of antimalarial drugs in clinical trials by quantitative PCR

Antimicrobial Agents and Chemotherapy

Volumn 59, Issue 7, 2015, Pages 4249-4259

  Marquart, Louise ^a   Baker, Mark ^b,d   O'Rourke, Peter ^a   McCarthy, James S ^a,c  

^a QIMR BERGHOFER MEDICAL RESEARCH INSTITUTE   (Australia)

^b Medicines for Malaria Venture   (Switzerland)

^c UNIVERSITY OF QUEENSLAND   (Australia)

^d Department of Toxicology   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIMALARIAL AGENT; ARTEMETHER PLUS BENFLUMETOL; MEFLOQUINE; PRIMAQUINE; PYRIMETHAMINE PLUS SULFADOXINE; DRUG COMBINATION; FANASIL, PYRIMETHAMINE DRUG COMBINATION; PYRIMETHAMINE; SULFADOXINE;

ADULT; AREA UNDER THE CURVE; ARTHRALGIA; ARTICLE; CLINICAL EVALUATION; COHORT ANALYSIS; CONFIDENCE INTERVAL; DIZZINESS; DRUG EFFECT; DRUG HALF LIFE; DRUG SAFETY; ELIMINATION HALF-LIFE; FATIGUE; FEVER; HEADACHE; HUMAN; HUMAN EXPERIMENT; LOGLINEAR MODEL; MALAISE; MALE; MAXIMUM PLASMA CONCENTRATION; METALLIC TASTE; MULTICENTER STUDY; MYALGIA; NAUSEA; NECK PAIN; NEUTROPHIL COUNT; NORMAL HUMAN; PAIN; PARASITE CLEARANCE; PARASITE REDUCTION RATE; PARASITEMIA; PHARMACODYNAMICS; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; RIGOR; SIDE EFFECT; SINGLE DRUG DOSE; STATISTICAL ANALYSIS; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; VALIDITY; ADOLESCENT; ALGORITHM; CLINICAL TRIAL; DRUG COMBINATION; FEMALE; HALF LIFE TIME; MALARIA; PARASITOLOGY; PROCEDURES; REPRODUCIBILITY; STATISTICAL MODEL; YOUNG ADULT;

ADOLESCENT; ADULT; ALGORITHMS; ANTIMALARIALS; AREA UNDER CURVE; DRUG COMBINATIONS; FEMALE; HALF-LIFE; HUMANS; MALARIA; MALE; MEFLOQUINE; MODELS, STATISTICAL; PARASITEMIA; POLYMERASE CHAIN REACTION; PYRIMETHAMINE; REPRODUCIBILITY OF RESULTS; SULFADOXINE; YOUNG ADULT;

EID: 84935882565     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.04942-14     Document Type: Article

References (28)

1. Dondorp AM, Fanello CI, Hendriksen IC, Gomes E, Seni A, Chhaganlal KD, Bojang K, Olaosebikan R, Anunobi N, Maitland K, Kivaya E, Agbenyega T, Nguah SB, Evans J, Gesase S, Kahabuka C, Mtove G, Nadjm B, Deen J, Mwanga-Amumpaire J, Nansumba M, Karema C, Umulisa N, Uwimana A, Mokuolu OA, Adedoyin OT, Johnson WB, Tshefu AK, Onyamboko MA, Sakulthaew T, Ngum WP, Silamut K, Stepniewska K, Woodrow CJ, Bethell D, Wills B, Oneko M, Peto TE, von Seidlein L, Day NP, White NJ. 2010. Artesunate versus quinine in the treatment of severe falciparum malaria in African children (AQUA-MAT): an open-label, randomised trial. Lancet 376:1647-1657. http://dx.doi.org/10.1016/S0140-6736(10)61924-1.
2. Amaratunga C, Sreng S, Suon S, Phelps ES, Stepniewska K, Lim P, Zhou C, Mao S, Anderson JM, Lindegardh N, Jiang H, Song J, Su XZ, White NJ, Dondorp AM, Anderson TJ, Fay MP, Mu J, Duong S, Fairhurst RM. 2012. Artemisinin-resistant Plasmodium falciparum in Pursat province, western Cambodia: a parasite clearance rate study. Lancet Infect Dis 12:851-858. http://dx.doi.org/10.1016/S1473-3099(12)70181-0.
3. Ashley EA, Dhorda M, Fairhurst RM, Amaratunga C, Lim P, Suon S, Sreng S, Anderson JM, Mao S, Sam B, Sopha C, Chuor CM, Nguon C, Sovannaroth S, Pukrittayakamee S, Jittamala P, Chotivanich K, Chutasmit K, Suchatsoonthorn C, Runcharoen R, Hien TT, Thuy-Nhien NT, Thanh NV, Phu NH, Htut Y, Han KT, Aye KH, Mokuolu OA, Olaosebikan RR, Folaranmi OO, Mayxay M, Khanthavong M, Hongvanthong B, Newton PN, Onyamboko MA, Fanello CI, Tshefu AK, Mishra N, Valecha N, Phyo AP, Nosten F, Yi P, Tripura R, Borrmann S, Bashraheil M, Peshu J, Faiz MA, Ghose A, Hossain MA, Samad R, Rahman MR, Hasan MM, Islam A, Miotto O, Amato R, MacInnis B, Stalker J, Kwiatkowski DP, Bozdech Z, Jeeyapant A, Cheah PY, Sakulthaew T, Chalk J, Intharabut B, Silamut K, Lee SJ, Vihokhern B, Kunasol C, Imwong M, Tarning J, Taylor WJ, Yeung S, Woodrow CJ, Flegg JA, Das D, Smith J, Venkatesan M, Plowe CV, Stepniewska K, Guerin PJ, Dondorp AM, Day NP, White NJ, Tracking Resistance to Artemisinin Collaboration (TRAC). 2014. Spread of artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 371:411-423. http://dx.doi.org/10.1056/NEJMoa1314981.
4. Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. 2009. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med 361:455-467. http://dx.doi.org/10.1056/NEJMoa0808859.
5. Phyo AP, Nkhoma S, Stepniewska K, Ashley EA, Nair S, McGready R, ler Moo C, Al-Saai S, Dondorp AM, Lwin KM, Singhasivanon P, Day NP, White NJ, Anderson TJ, Nosten F. 2012. Emergence of artemisinin-resistant malaria on the western border of Thailand: a longitudinal study. Lancet 379: 1960-1966. http://dx.doi.org/10.1016/S0140-6736(12)60484-X.
6. Noedl H, Wongsrichanalai C, Miller RS, Myint KS, Looareesuwan S, Sukthana Y, Wongchotigul V, Kollaritsch H, Wiedermann G, Wernsdorfer WH. 2002. Plasmodium falciparum: effect of anti-malarial drugs on the production and secretion characteristics of histidine-rich protein II. Exp Parasitol 102:157-163. http://dx.doi.org/10.1016/S0014-4894(03)00051-1.
7. Marquart L, Butterworth A, McCarthy JS, Gatton ML. 2012. Modelling the dynamics of Plasmodium falciparum histidine-rich protein 2 in human malaria to better understand malaria rapid diagnostic test performance. Malar J 11:74. http://dx.doi.org/10.1186/1475-2875-11-74.
8. Li TS, Tubiana R, Katlama C, Calvez V, Ait Mohand H, Autran B. 1998. Long-lasting recovery in CD4 T-cell function and viral-load reduction after highly active antiretroviral therapy in advanced HIV-1 disease. Lancet 351:1682-1686. http://dx.doi.org/10.1016/S0140-6736(97)10291-4.
9. Lawrence G, Cheng QQ, Reed C, Taylor D, Stowers A, Cloonan N, Rzepczyk C, Smillie A, Anderson K, Pombo D, Allworth A, Eisen D, Anders R, Saul A. 2000. Effect of vaccination with 3 recombinant asexual-stage malaria antigens on initial growth rates of Plasmodium falciparum in non-immune volunteers. Vaccine 18:1925-1931. http://dx.doi.org/10.1016/S0264-410X(99)00444-2.
10. McCarthy JS, Sekuloski S, Griffin PM, Elliott S, Douglas N, Peatey C, Rockett R, O'Rourke P, Marquart L, Hermsen C, Duparc S, Mohrle J, Trenholme KR, Humberstone AJ. 2011. A pilot randomised trial of induced blood-stage Plasmodium falciparum infections in healthy volunteers for testing efficacy of new antimalarial drugs. PLoS One 6:e21914. http://dx.doi.org/10.1371/journal.pone.0021914.
11. Mens PF, Sawa P, van Amsterdam SM, Versteeg I, Omar SA, Schallig HD, Kager PA. 2008. A randomized trial to monitor the efficacy and effectiveness by QT-NASBA of artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment and transmission control of uncomplicated Plasmodium falciparum malaria in western Kenya. Malar J 7:237. http://dx.doi.org/10.1186/1475-2875-7-237.
12. Murphy SC, Prentice JL, Williamson K, Wallis CK, Fang FC, Fried M, Pinzon C, Wang R, Talley AK, Kappe SH, Duffy PE, Cookson BT. 2012. Real-time quantitative reverse transcription PCR for monitoring of blood-stage Plasmodium falciparum infections in malaria human challenge trials. Am J Trop Med Hyg 86:383-394. http://dx.doi.org/10.4269/ajtmh.2012.10-0658.
13. Flegg JA, Guerin PJ, White NJ, Stepniewska K. 2011. Standardizing the measurement of parasite clearance in falciparum malaria: the parasite clearance estimator. Malar J 10:339. http://dx.doi.org/10.1186/1475-2875-10-339.
14. White NJ. 2011. The parasite clearance curve. Malar J 10:278. http://dx.doi.org/10.1186/1475-2875-10-278.
15. White NJ. 1997. Assessment of the pharmacodynamic properties of anti-malarial drugs in vivo. Antimicrob Agents Chemother 41:1413-1422.
16. Engwerda CR, Minigo G, Amante FH, McCarthy JS. 2012. Experimentally induced blood stage malaria infection as a tool for clinical research. Trends Parasitol 28:515-521. http://dx.doi.org/10.1016/j.pt.2012.09.001.
17. Bell DJ, Nyirongo SK, Molyneux ME, Winstanley PA, Ward SA. 2007. Practical HPLC methods for the quantitative determination of common antimalarials in Africa. J Chromatogr B Analyt Technol Biomed Life Sci 847:231-236. http://dx.doi.org/10.1016/j.jchromb.2006.10.020.
18. US Department of Health and Human Services. 2010. Common terminology criteria for adverse events (CTCAE), version 4.03. National Cancer Institute, National Institutes of Health, US Department of Health and Human Services, Washington, DC. http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf.
19. Rockett RJ, Tozer SJ, Peatey C, Bialasiewicz S, Whiley DM, Nissen MD, Trenholme K, Mc Carthy JS, Sloots TP. 2011. A real-time, quantitative PCR method using hydrolysis probes for the monitoring of Plasmodium falciparum load in experimentally infected human volunteers. Malar J 10:48. http://dx.doi.org/10.1186/1475-2875-10-48.
20. Beal SL. 2001. Ways to fit a PK model with some data below the quantification limit. J Pharmacokinet Pharmacodyn 28:481-504. http://dx.doi.org/10.1023/A:1012299115260.
21. Hartung J, Knapp G, Sinha B. 2008. Statistical meta-analysis with applications, p 35-41. John Wiley & Sons, Inc, Hoboken, NJ.
22. nd ed. Russell Sage Foundation, New York, NY.
23. Barnes KI, Little F, Smith PJ, Evans A, Watkins WM, White NJ. 2006. Sulfadoxine-pyrimethamine pharmacokinetics in malaria: pediatric dosing implications. Clin Pharmacol Ther 80:582-596. http://dx.doi.org/10.1016/j.clpt.2006.08.016.
24. Weidekamm E, Plozza-Nottebrock H, Forgo I, Dubach UC. 1982. Plasma concentrations in pyrimethamine and sulfadoxine and evaluation of pharmacokinetic data by computerized curve fitting. Bull World Health Organ 60:115-122.
25. ter Kuile F, White NJ, Holloway P, Pasvol G, Krishna S. 1993. Plasmodium falciparum: in vitro studies of the pharmacodynamic properties of drugs used for the treatment of severe malaria. Exp Parasitol 76:85-95. http://dx.doi.org/10.1006/expr.1993.1010.
26. Senn S, Holford N, Hockey H. 2012. The ghosts of departed quantities: approaches to dealing with observations below the limit of quantification. Stat Med 31:4280-4295. http://dx.doi.org/10.1002/sim.5515.
27. Bergstrand M, Karlsson M. 2009. Handling data below the limit of quantification in mixed effects models. AAPS J 11:371-380. http://dx.doi.org/10.1208/s12248-009-9112-5.
28. Tobin J. 1958. Estimation of relationships of limited dependent variables. Econometrica 26:24-36. http://dx.doi.org/10.2307/1907382.