-
1
-
-
85011664717
-
What we may expect from novel antibacterial agents in the pipeline with respect to resistance and pharmacodynamic principles
-
Bush K, Page MGP. What we may expect from novel antibacterial agents in the pipeline with respect to resistance and pharmacodynamic principles. J Pharmacokinet Pharmacodyn 2017; 44:1-20.
-
(2017)
J Pharmacokinet Pharmacodyn
, vol.44
, pp. 1-20
-
-
Bush, K.1
Page, M.G.P.2
-
2
-
-
84931275542
-
Challenges and solutions for clinical development of new antibacterial agents: Results of a survey among pharmaceutical industry professionals
-
Bettiol E, Wetherington JD, Schmitt N, Harbarth S; COMBACTE consortium. Challenges and solutions for clinical development of new antibacterial agents: results of a survey among pharmaceutical industry professionals. Antimicrob Agents Chemother 2015; 59:3695-9.
-
(2015)
Antimicrob Agents Chemother
, vol.59
, pp. 3695-3699
-
-
Bettiol, E.1
Wetherington, J.D.2
Schmitt, N.3
Harbarth, S.4
-
3
-
-
84866666082
-
White paper: Recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens
-
Infectious Diseases Society of America
-
Infectious Diseases Society of America. White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens. Clin Infect Dis 2012; 55:1031-46.
-
(2012)
Clin Infect Dis
, vol.55
, pp. 1031-1046
-
-
-
6
-
-
85021844786
-
Progress in the fight against multidrug-resistant bacteria 2005-2016: Modern noninferiority trial designs enable antibiotic development in advance of epidemic bacterial resistance
-
Rex JH, Talbot GH, Goldberger MJ, et al. Progress in the fight against multidrug-resistant bacteria 2005-2016: modern noninferiority trial designs enable antibiotic development in advance of epidemic bacterial resistance. Clin Infect Dis 2017; 65:141-6.
-
(2017)
Clin Infect Dis
, vol.65
, pp. 141-146
-
-
Rex, J.H.1
Talbot, G.H.2
Goldberger, M.J.3
-
8
-
-
84959919724
-
The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance
-
Kostyanev T, Bonten MJ, O'Brien S, et al. The Innovative Medicines Initiative's New Drugs for Bad Bugs programme: European public-private partnerships for the development of new strategies to tackle antibiotic resistance. J Antimicrob Chemother 2016; 71:290-5.
-
(2016)
J Antimicrob Chemother
, vol.71
, pp. 290-295
-
-
Kostyanev, T.1
Bonten, M.J.2
O'Brien, S.3
-
9
-
-
85065925930
-
-
Accessed 3 July 2018
-
Innovative Medicines Initiative. 6th Call for proposals. 2012. Available at: https://ec.europa.eu/research/participants/portal4/doc/call/fp7/imi-ju-06-2012/32291-call_topic_imi_ju_2012_6th_call_for_proposals_en.pdf. Accessed 3 July 2018.
-
(2012)
6th Call for Proposals
-
-
-
10
-
-
84994718447
-
Non-linear absorption pharmacokinetics of amoxicillin: Consequences for dosing regimens and clinical breakpoints
-
de Velde F, de Winter BC, Koch BC, van Gelder T, Mouton JW; COMBACTE-NET consortium. Non-linear absorption pharmacokinetics of amoxicillin: consequences for dosing regimens and clinical breakpoints. J Antimicrob Chemother 2016; 71:2909-17.
-
(2016)
J Antimicrob Chemother
, vol.71
, pp. 2909-2917
-
-
De Velde, F.1
De Winter, B.C.2
Koch, B.C.3
Van Gelder, T.4
Mouton, J.W.5
-
12
-
-
85020117425
-
Adaptive power priors with empirical Bayes for clinical trials
-
Gravestock I, Held L; COMBACTE-Net consortium. Adaptive power priors with empirical Bayes for clinical trials. Pharm Stat 2017; 16:349-60.
-
(2017)
Pharm Stat
, vol.16
, pp. 349-360
-
-
Gravestock, I.1
Held, L.2
-
13
-
-
85039765120
-
Assessing non-inferiority in treatment trials regarding severe infectious diseases: An extension to the entire follow-up period using a cure-death multistate model
-
Sommer H, Bluhmki T, Beyersmann J, et al; COMBACTE-NET. Assessing non-inferiority in treatment trials regarding severe infectious diseases: an extension to the entire follow-up period using a cure-death multistate model. Antimicrob Agents Chemother 2018; 62:e01691-17.
-
(2018)
Antimicrob Agents Chemother
, vol.62
, pp. e01691-e01717
-
-
Sommer, H.1
Bluhmki, T.2
Beyersmann, J.3
-
14
-
-
85044514703
-
Bezlotoxumab and recurrent Clostridium difficile infection
-
Sommer H, Timsit JF, Wolkewitz M; COMBACTE-NET consortium. Bezlotoxumab and recurrent Clostridium difficile infection. N Engl J Med 2017; 376:1594.
-
(2017)
N Engl J Med
, vol.376
, pp. 1594
-
-
Sommer, H.1
Timsit, J.F.2
Wolkewitz, M.3
-
15
-
-
85020454217
-
The time-dependent “cure-death” model investigating two equally important endpoints simultaneously in trials treating high-risk patients with resistant pathogens
-
Sommer H, Wolkewitz M, Schumacher M; COMBACTE-NET consortium. The time-dependent “cure-death” model investigating two equally important endpoints simultaneously in trials treating high-risk patients with resistant pathogens. Pharm Stat 2017; 16:267-79.
-
(2017)
Pharm Stat
, vol.16
, pp. 267-279
-
-
Sommer, H.1
Wolkewitz, M.2
Schumacher, M.3
-
16
-
-
85018454702
-
Appropriate endpoints for evaluation of new antibiotic therapies for severe infections: A perspective from COMBACTE's STAT-Net
-
Timsit JF, de Kraker MEA, Sommer H, et al; COMBACTE-NET consortium. Appropriate endpoints for evaluation of new antibiotic therapies for severe infections: a perspective from COMBACTE's STAT-Net. Intensive Care Med 2017; 43:1002-12.
-
(2017)
Intensive Care Med
, vol.43
, pp. 1002-1012
-
-
Timsit, J.F.1
De Kraker, M.E.A.2
Sommer, H.3
-
17
-
-
85021257061
-
Treatment of severe hospital-acquired and ventilator-associated pneumonia: A systematic review of inclusion and judgment criteria used in randomized controlled trials
-
Weiss E, Essaied W, Adrie C, Zahar JR, Timsit JF. Treatment of severe hospital-acquired and ventilator-associated pneumonia: a systematic review of inclusion and judgment criteria used in randomized controlled trials. Crit Care 2017; 21:162.
-
(2017)
Crit Care
, vol.21
, pp. 162
-
-
Weiss, E.1
Essaied, W.2
Adrie, C.3
Zahar, J.R.4
Timsit, J.F.5
-
19
-
-
85052489724
-
Highly variable absorption of clavulanic acid during the day: A population pharmacokinetic analysis
-
De Velde F, De Winter BCM, Koch BCP, Van Gelder T, Mouton JW. Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. J Antimicrob Chemother 2018; 73:469-76.
-
(2018)
J Antimicrob Chemother
, vol.73
, pp. 469-476
-
-
De Velde, F.1
De Winter, B.C.M.2
Koch, B.C.P.3
Van Gelder, T.4
Mouton, J.W.5
-
20
-
-
84942122477
-
Use of old antibiotics now and in the future from a pharmacokinetic/pharmacodynamic perspective
-
Muller AE, Theuretzbacher U, Mouton JW. Use of old antibiotics now and in the future from a pharmacokinetic/pharmacodynamic perspective. Clin Microbiol Infect 2015; 21:881-5.
-
(2015)
Clin Microbiol Infect
, vol.21
, pp. 881-885
-
-
Muller, A.E.1
Theuretzbacher, U.2
Mouton, J.W.3
-
22
-
-
84971406392
-
-
Guidance for Industry. Accessed 10 November 2017
-
Food and Drug Administration. Complicated urinary tract infections: developing drugs for treament. Guidance for Industry. 2015. Available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ UCM070981.pdf. Accessed 10 November 2017.
-
(2015)
Complicated Urinary Tract Infections: Developing Drugs for Treament
-
-
-
24
-
-
84862942215
-
The win ratio: A new approach to the analysis of composite endpoints in clinical trials based on clinical priorities
-
Pocock SJ, Ariti CA, Collier TJ, Wang D. The win ratio: a new approach to the analysis of composite endpoints in clinical trials based on clinical priorities. Eur Heart J 2012; 33:176-82.
-
(2012)
Eur Heart J
, vol.33
, pp. 176-182
-
-
Pocock, S.J.1
Ariti, C.A.2
Collier, T.J.3
Wang, D.4
-
25
-
-
84942023902
-
Desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR)
-
Evans SR, Rubin D, Follmann D, et al. Desirability of outcome ranking (DOOR) and response adjusted for duration of antibiotic risk (RADAR). Clin Infect Dis 2015; 61:800-6.
-
(2015)
Clin Infect Dis
, vol.61
, pp. 800-806
-
-
Evans, S.R.1
Rubin, D.2
Follmann, D.3
-
26
-
-
85040557388
-
Colistin versus ceftazidime-avibactam in the treatment of infections due to carbapenem-resistant Enterobacteriaceae
-
van Duin D, Lok JJ, Earley M, et al. Colistin versus ceftazidime-avibactam in the treatment of infections due to carbapenem-resistant Enterobacteriaceae. Clin Infect Dis 2018; 66:163-71.
-
(2018)
Clin Infect Dis
, vol.66
, pp. 163-171
-
-
Van Duin, D.1
Lok, J.J.2
Earley, M.3
-
27
-
-
85021128434
-
Response adjusted for days of antibiotic risk (RADAR): Evaluation of a novel method to compare strategies to optimize antibiotic use
-
Schweitzer VA, van Smeden M, Postma DF, Oosterheert JJ, Bonten MJM, van Werkhoven CH. Response adjusted for days of antibiotic risk (RADAR): evaluation of a novel method to compare strategies to optimize antibiotic use. Clin Microbiol Infect 2017; 23:980-5.
-
(2017)
Clin Microbiol Infect
, vol.23
, pp. 980-985
-
-
Schweitzer, V.A.1
Van Smeden, M.2
Postma, D.F.3
Oosterheert, J.J.4
Bonten, M.J.M.5
Van Werkhoven, C.H.6
-
29
-
-
84881514498
-
Weak convergence of the wild bootstrap for the Aalen-Johansen estimator of the cumulative incidence function of a competing risk
-
Beyersmann J, Di Termini S, Pauly M. Weak convergence of the wild bootstrap for the Aalen-Johansen estimator of the cumulative incidence function of a competing risk. Scand J Stat 2013; 40:387-402.
-
(2013)
Scand J Stat
, vol.40
, pp. 387-402
-
-
Beyersmann, J.1
Di Termini, S.2
Pauly, M.3
-
30
-
-
0030915453
-
Non-parametric inference for cumulative incidence functions in competing risks studies
-
Lin DY. Non-parametric inference for cumulative incidence functions in competing risks studies. Stat Med 1997; 16:901-10.
-
(1997)
Stat Med
, vol.16
, pp. 901-910
-
-
Lin, D.Y.1
-
31
-
-
84927574624
-
Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance
-
Huque MF, Valappil T, Soon GG. Hierarchical nested trial design (HNTD) for demonstrating treatment efficacy of new antibacterial drugs in patient populations with emerging bacterial resistance. Stat Med 2014; 33:4321-36.
-
(2014)
Stat Med
, vol.33
, pp. 4321-4336
-
-
Huque, M.F.1
Valappil, T.2
Soon, G.G.3
-
33
-
-
84919644416
-
Robust meta-analytic-predictive priors in clinical trials with historical control information
-
Schmidli H, Gsteiger S, Roychoudhury S, O'Hagan A, Spiegelhalter D, Neuenschwander B. Robust meta-analytic-predictive priors in clinical trials with historical control information. Biometrics 2014; 70:1023-32.
-
(2014)
Biometrics
, vol.70
, pp. 1023-1032
-
-
Schmidli, H.1
Gsteiger, S.2
Roychoudhury, S.3
O'Hagan, A.4
Spiegelhalter, D.5
Neuenschwander, B.6
-
34
-
-
84887992906
-
Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: A randomised, double-blind, placebo-controlled trial
-
Baeten D, Baraliakos X, Braun J, et al. Anti-interleukin-17A monoclonal antibody secukinumab in treatment of ankylosing spondylitis: a randomised, double-blind, placebo-controlled trial. Lancet 2013; 382:1705-13.
-
(2013)
Lancet
, vol.382
, pp. 1705-1713
-
-
Baeten, D.1
Baraliakos, X.2
Braun, J.3
-
35
-
-
84868680312
-
Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: Unexpected results of a randomised, double-blind placebo-controlled trial
-
Hueber W, Sands BE, Lewitzky S, et al; Secukinumab in Crohn's Disease Study Group. Secukinumab, a human anti-IL-17A monoclonal antibody, for moderate to severe Crohn's disease: unexpected results of a randomised, double-blind placebo-controlled trial. Gut 2012; 61:1693-700.
-
(2012)
Gut
, vol.61
, pp. 1693-1700
-
-
Hueber, W.1
Sands, B.E.2
Lewitzky, S.3
-
36
-
-
84878258333
-
Adaptive adjustment of the randomization ratio using historical control data
-
Hobbs BP, Carlin BP, Sargent DJ. Adaptive adjustment of the randomization ratio using historical control data. Clin Trials 2013; 10:430-40.
-
(2013)
Clin Trials
, vol.10
, pp. 430-440
-
-
Hobbs, B.P.1
Carlin, B.P.2
Sargent, D.J.3
-
37
-
-
84922718233
-
-
Accessed 24 January 2018
-
President's Council of Advisors on Science and Technology (PCAST). Report to the president on combating antibiotic resistance. 2014. Available at: www.broadinstitute.org/files/sections/about/PCAST/2014%20pcast-amr.pdf. Accessed 24 January 2018.
-
(2014)
Report to the President on Combating Antibiotic Resistance
-
-
-
38
-
-
84907953363
-
Use of historical control data for assessing treatment effects in clinical trials
-
Viele K, Berry S, Neuenschwander B, et al. Use of historical control data for assessing treatment effects in clinical trials. Pharm Stat 2014; 13:41-54.
-
(2014)
Pharm Stat
, vol.13
, pp. 41-54
-
-
Viele, K.1
Berry, S.2
Neuenschwander, B.3
-
39
-
-
84928739516
-
The platform trial: An efficient strategy for evaluating multiple treatments
-
Berry SM, Connor JT, Lewis RJ. The platform trial: an efficient strategy for evaluating multiple treatments. JAMA 2015; 313:1619-20.
-
(2015)
JAMA
, vol.313
, pp. 1619-1620
-
-
Berry, S.M.1
Connor, J.T.2
Lewis, R.J.3
-
40
-
-
85021823745
-
Master protocols to study multiple therapies, multiple diseases, or both
-
Woodcock J, LaVange LM. Master protocols to study multiple therapies, multiple diseases, or both. N Engl J Med 2017; 377:62-70.
-
(2017)
N Engl J Med
, vol.377
, pp. 62-70
-
-
Woodcock, J.1
LaVange, L.M.2
-
41
-
-
84978064544
-
Adaptive designs for clinical trials
-
Bhatt DL, Mehta C. Adaptive designs for clinical trials. N Engl J Med 2016; 375:65-74.
-
(2016)
N Engl J Med
, vol.375
, pp. 65-74
-
-
Bhatt, D.L.1
Mehta, C.2
-
43
-
-
85010866375
-
Efficient delivery of investigational antibacterial agents via sustainable clinical trial networks
-
McDonnell A, Rex JH, Goossens H, Bonten M, Fowler VG Jr, Dane A. Efficient delivery of investigational antibacterial agents via sustainable clinical trial networks. Clin Infect Dis 2016; 63(suppl 2):S57-9.
-
(2016)
Clin Infect Dis
, vol.63
, pp. S57-S59
-
-
McDonnell, A.1
Rex, J.H.2
Goossens, H.3
Bonten, M.4
Fowler, V.G.5
Dane, A.6
-
44
-
-
85042530483
-
Studying new antibiotics for multidrug resistant infections: Are today's patients paying for unproved future benefits?
-
Powers JH, Evans SR, Kesselheim AS. Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits? BMJ 2018; 360:k587.
-
(2018)
BMJ
, vol.360
, pp. k587
-
-
Powers, J.H.1
Evans, S.R.2
Kesselheim, A.S.3
-
46
-
-
79957811079
-
Understanding competing risks: A simulation point of view
-
Allignol A, Schumacher M, Wanner C, Drechsler C, Beyersmann J. Understanding competing risks: a simulation point of view. BMC Med Res Methodol 2011; 11:86.
-
(2011)
BMC Med Res Methodol
, vol.11
, pp. 86
-
-
Allignol, A.1
Schumacher, M.2
Wanner, C.3
Drechsler, C.4
Beyersmann, J.5
-
47
-
-
84904501674
-
Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies
-
Dane A, Wetherington JD. Statistical considerations associated with a comprehensive regulatory framework to address the unmet need for new antibacterial therapies. Pharm Stat 2014; 13:222-8.
-
(2014)
Pharm Stat
, vol.13
, pp. 222-228
-
-
Dane, A.1
Wetherington, J.D.2
-
48
-
-
84955255784
-
Making what's advanced today routine tomorrow
-
Ruberg SJ. Making what's advanced today routine tomorrow. J Biopharm Stat 2016; 26:55-70.
-
(2016)
J Biopharm Stat
, vol.26
, pp. 55-70
-
-
Ruberg, S.J.1
|