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Phase II dose-ranging trial of the early bactericidal activity of PA-824.
Diacon AH, Dawson R, du Bois J, Narunsky K, Venter A, Donald PR, van Niekerk C, Erondu N, Ginsberg AM, Becker P, Spigelman MK. Diacon AH, et al. Among authors: spigelman mk. Antimicrob Agents Chemother. 2012 Jun;56(6):3027-31. doi: 10.1128/AAC.06125-11. Epub 2012 Mar 19. Antimicrob Agents Chemother. 2012. PMID: 22430968 Free PMC article. Clinical Trial.
The ethics of non-inferiority trials.
Nunn AJ, Meredith SK, Spigelman MK, Ginsberg AM, Gillespie SH. Nunn AJ, et al. Among authors: spigelman mk. Lancet. 2008 Mar 15;371(9616):895; author reply 896-7. doi: 10.1016/S0140-6736(08)60404-3. Lancet. 2008. PMID: 18342678 No abstract available.
Safety, tolerability, and pharmacokinetics of PA-824 in healthy subjects.
Ginsberg AM, Laurenzi MW, Rouse DJ, Whitney KD, Spigelman MK. Ginsberg AM, et al. Among authors: spigelman mk. Antimicrob Agents Chemother. 2009 Sep;53(9):3720-5. doi: 10.1128/AAC.00106-09. Epub 2009 Jun 15. Antimicrob Agents Chemother. 2009. PMID: 19528280 Free PMC article. Clinical Trial.
Early bactericidal activity and pharmacokinetics of PA-824 in smear-positive tuberculosis patients.
Diacon AH, Dawson R, Hanekom M, Narunsky K, Maritz SJ, Venter A, Donald PR, van Niekerk C, Whitney K, Rouse DJ, Laurenzi MW, Ginsberg AM, Spigelman MK. Diacon AH, et al. Among authors: spigelman mk. Antimicrob Agents Chemother. 2010 Aug;54(8):3402-7. doi: 10.1128/AAC.01354-09. Epub 2010 May 24. Antimicrob Agents Chemother. 2010. PMID: 20498324 Free PMC article. Clinical Trial.
Efficiency and safety of the combination of moxifloxacin, pretomanid (PA-824), and pyrazinamide during the first 8 weeks of antituberculosis treatment: a phase 2b, open-label, partly randomised trial in patients with drug-susceptible or drug-resistant pulmonary tuberculosis.
Dawson R, Diacon AH, Everitt D, van Niekerk C, Donald PR, Burger DA, Schall R, Spigelman M, Conradie A, Eisenach K, Venter A, Ive P, Page-Shipp L, Variava E, Reither K, Ntinginya NE, Pym A, von Groote-Bidlingmaier F, Mendel CM. Dawson R, et al. Lancet. 2015 May 2;385(9979):1738-1747. doi: 10.1016/S0140-6736(14)62002-X. Epub 2015 Mar 18. Lancet. 2015. PMID: 25795076 Clinical Trial.
Tuberculosis.
Pai M, Behr MA, Dowdy D, Dheda K, Divangahi M, Boehme CC, Ginsberg A, Swaminathan S, Spigelman M, Getahun H, Menzies D, Raviglione M. Pai M, et al. Nat Rev Dis Primers. 2016 Oct 27;2:16076. doi: 10.1038/nrdp.2016.76. Nat Rev Dis Primers. 2016. PMID: 27784885 Review.
Toxicity associated with tuberculosis chemotherapy in the REMoxTB study.
Tweed CD, Crook AM, Amukoye EI, Dawson R, Diacon AH, Hanekom M, McHugh TD, Mendel CM, Meredith SK, Murphy ME, Murthy SE, Nunn AJ, Phillips PPJ, Singh KP, Spigelman M, Wills GH, Gillespie SH. Tweed CD, et al. BMC Infect Dis. 2018 Jul 11;18(1):317. doi: 10.1186/s12879-018-3230-6. BMC Infect Dis. 2018. PMID: 29996783 Free PMC article.
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