Revisiting the Design of Phase III Clinical Trials of Antimalarial Drugs for Uncomplicated Plasmodium Falciparum Malaria

Overview

Journal PLoS Med

Specialty General Medicine

Date 2008 Nov 21

PMID 19018658

Citations 8

Authors

Steffen Borrmann

Tim Peto

Robert W Snow

Win Gutteridge

Nicholas J White

Affiliations

Soon will be listed here.

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References

Price R, Hasugian A, Ratcliff A, Siswantoro H, Purba H, Kenangalem E . Clinical and pharmacological determinants of the therapeutic response to dihydroartemisinin-piperaquine for drug-resistant malaria. Antimicrob Agents Chemother. 2007; 51(11):4090-7. PMC: 2151469. DOI: 10.1128/AAC.00486-07. View

Kamya M, Yeka A, Bukirwa H, Lugemwa M, Rwakimari J, Staedke S . Artemether-lumefantrine versus dihydroartemisinin-piperaquine for treatment of malaria: a randomized trial. PLoS Clin Trials. 2007; 2(5):e20. PMC: 1876597. DOI: 10.1371/journal.pctr.0020020. View

Piola P, Fogg C, Bajunirwe F, Biraro S, Grandesso F, Ruzagira E . Supervised versus unsupervised intake of six-dose artemether-lumefantrine for treatment of acute, uncomplicated Plasmodium falciparum malaria in Mbarara, Uganda: a randomised trial. Lancet. 2005; 365(9469):1467-73. DOI: 10.1016/S0140-6736(05)66416-1. View

Price R, Uhlemann A, van Vugt M, Brockman A, Hutagalung R, Nair S . Molecular and pharmacological determinants of the therapeutic response to artemether-lumefantrine in multidrug-resistant Plasmodium falciparum malaria. Clin Infect Dis. 2006; 42(11):1570-7. PMC: 4337983. DOI: 10.1086/503423. View

Djimde A, Doumbo O, Traore O, Guindo A, Kayentao K, Diourte Y . Clearance of drug-resistant parasites as a model for protective immunity in Plasmodium falciparum malaria. Am J Trop Med Hyg. 2003; 69(5):558-63. View

Zongo I, Dorsey G, Rouamba N, Tinto H, Dokomajilar C, Guiguemde R . Artemether-lumefantrine versus amodiaquine plus sulfadoxine-pyrimethamine for uncomplicated falciparum malaria in Burkina Faso: a randomised non-inferiority trial. Lancet. 2007; 369(9560):491-8. DOI: 10.1016/S0140-6736(07)60236-0. View

Snow R, Guerra C, Noor A, Myint H, Hay S . The global distribution of clinical episodes of Plasmodium falciparum malaria. Nature. 2005; 434(7030):214-7. PMC: 3128492. DOI: 10.1038/nature03342. View

Uhlemann A, McGready R, Ashley E, Brockman A, Singhasivanon P, Krishna S . Intrahost selection of Plasmodium falciparum pfmdr1 alleles after antimalarial treatment on the northwestern border of Thailand. J Infect Dis. 2006; 195(1):134-41. PMC: 4337981. DOI: 10.1086/509809. View

Bathurst I, Hentschel C . Medicines for Malaria Venture: sustaining antimalarial drug development. Trends Parasitol. 2006; 22(7):301-7. DOI: 10.1016/j.pt.2006.05.011. View

10.

Collins W, Greenhouse B, Rosenthal P, Dorsey G . The use of genotyping in antimalarial clinical trials: a systematic review of published studies from 1995-2005. Malar J. 2006; 5:122. PMC: 1716173. DOI: 10.1186/1475-2875-5-122. View

11.

Stepniewska K, Taylor W, Mayxay M, Price R, Smithuis F, Guthmann J . In vivo assessment of drug efficacy against Plasmodium falciparum malaria: duration of follow-up. Antimicrob Agents Chemother. 2004; 48(11):4271-80. PMC: 525402. DOI: 10.1128/AAC.48.11.4271-4280.2004. View

12.

Staedke S, Mpimbaza A, Kamya M, Nzarubara B, Dorsey G, Rosenthal P . Combination treatments for uncomplicated falciparum malaria in Kampala, Uganda: randomised clinical trial. Lancet. 2004; 364(9449):1950-7. DOI: 10.1016/S0140-6736(04)17478-3. View

13.

White N . How antimalarial drug resistance affects post-treatment prophylaxis. Malar J. 2008; 7:9. PMC: 2254426. DOI: 10.1186/1475-2875-7-9. View

14.

Gatton M, Cheng Q . Can estimates of antimalarial efficacy from field studies be improved?. Trends Parasitol. 2008; 24(2):68-73. PMC: 2646162. DOI: 10.1016/j.pt.2007.11.003. View

15.

Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung R, Laihad F . Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007; 369(9563):757-765. PMC: 2532500. DOI: 10.1016/S0140-6736(07)60160-3. View

16.

Guthmann J, Pinoges L, Checchi F, Cousens S, Balkan S, Van Herp M . Methodological issues in the assessment of antimalarial drug treatment: analysis of 13 studies in eight African countries from 2001 to 2004. Antimicrob Agents Chemother. 2006; 50(11):3734-9. PMC: 1635238. DOI: 10.1128/AAC.01618-05. View

17.

Tarning J, Lindegardh N, Annerberg A, Singtoroj T, Day N, Ashton M . Pitfalls in estimating piperaquine elimination. Antimicrob Agents Chemother. 2005; 49(12):5127-8. PMC: 1315981. DOI: 10.1128/AAC.49.12.5127-5128.2005. View

18.

Mutabingwa T . Artemisinin-based combination therapies (ACTs): best hope for malaria treatment but inaccessible to the needy!. Acta Trop. 2005; 95(3):305-15. DOI: 10.1016/j.actatropica.2005.06.009. View

19.

Price R, Dorsey G, Ashley E, Barnes K, Baird J, DAlessandro U . World Antimalarial Resistance Network I: clinical efficacy of antimalarial drugs. Malar J. 2007; 6:119. PMC: 2008205. DOI: 10.1186/1475-2875-6-119. View

20.

Jones B, Jarvis P, Lewis J, Ebbutt A . Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996; 313(7048):36-9. PMC: 2351444. DOI: 10.1136/bmj.313.7048.36. View