White paper: Developing antimicrobial drugs for resistant pathogens, narrow-spectrum indications, and unmet needs

Journal of Infectious Diseases

Volumn 216, Issue 2, 2017, Pages 228-236

  Boucher, Helen W ^a   Ambrose, Paul G ^c   Chambers, H F ^e   Ebright, Richard H ^f   Jezek, Amanda ^g   Murray, Barbara E ^h   Newland, Jason G ⁱ   Ostrowsky, Belinda ^d   Rex, John H ^b,j,k  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b CARB X   (United States)

^c INSTITUTE FOR CLINICAL PHARMACODYNAMICS   (United States)

^d ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f RUTGERS UNIVERSITY   (United States)

^g Infectious Diseases Society of America Emerging Infections Network   (United States)

^h UNIVERSITY OF TEXAS MEDICAL SCHOOL   (United States)

ⁱ ST LOUIS CHILDREN S HOSPITAL   (United States)

^j F2G LTD   (United Kingdom)

^k WELLCOME TRUST SANGER INSTITUTE   (United Kingdom)

more..

Author keywords

Antibiotic development; Antimicrobial resistance

Indexed keywords

ANTIINFECTIVE AGENT;

ANIMAL MODEL; ANTIBIOTIC RESISTANCE; ARTICLE; DIAGNOSTIC TEST; DRUG DOSE REGIMEN; DRUG INDICATION; DRUG LABELING; DRUG USE; FEASIBILITY STUDY; FOOD AND DRUG ADMINISTRATION; HUMAN; HUMAN NEEDS; NONHUMAN; PHARMACODYNAMICS; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); RAPID TEST; UNCERTAINTY; VALIDATION STUDY; ANIMAL; DRUG DEVELOPMENT; GRAM NEGATIVE BACTERIUM; METHODOLOGY; MULTIDRUG RESISTANCE; PATHOGENICITY; TRENDS;

ANIMALS; ANTI-BACTERIAL AGENTS; DRUG DISCOVERY; DRUG RESISTANCE, MULTIPLE, BACTERIAL; GRAM-NEGATIVE BACTERIA; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN;

EID: 85027869554     PISSN: 00221899     EISSN: 15376613     Source Type: Journal    
DOI: 10.1093/infdis/jix211     Document Type: Article

References (50)

1. O'Neill, J; The Review on Antimicrobial Resistance. Tackling drug-resistant infections globally: final report and recommendations. 2016. http://amr-review.org/sites/default/files/160525-Final%20paper-with%20cover.pdf. Accessed 25 August 2016.
2. Pogue JM, Ortwine JK, Kaye KS. Optimal usage of colistin: are we any closer? Clin Infect Dis 2015; 61:1778-80.
3. Xavier BB, Lammens C, Ruhal R, et al. Identification of a novel plasmid-mediated colistin-resistance gene, mcr-2, in Escherichia coli, Belgium, June 2016. Euro Surveill 2016; 21:1-6. doi:10.2807/1560,7917.ES.2016.21.27.30280.
4. McGann P, Snesrud E, Maybank R, et al. Escherichia coli harboring mcr-1 and blaCTX-M on a novel IncF plasmid: first report of mcr-1 in the United States. Antimicrob Agents Chemother 2016; 60:4420-1.
5. Abbasi J. Infectious disease expert sees threat from colistin-resistant superbug. JAMA 2016; 316:806-7.
6. Boucher HW, Bakken JS, Murray BE. The United Nations and the urgent need for coordinated global action in the fight against antimicrobial resistance. Ann Intern Med 2016; 165:812-3.
7. Presidential Advisory Council on Combating Antibiotic Resistant Bacteria. Report 1: initial assessments of the national action plan for combating antibioticresistant bacteria. 2016. https://www.hhs.gov/sites/default/files/paccarb-finalreport-03312016.pdf. Accessed 25 August 2016
8. World Health Organization. Antimicrobial resistance: global report on surveillance. 2014. http://apps.who.int/iris/bitstream/10665/112642/1/9789241564748-eng.pdf?ua=1. Accessed 25 August 2016.
9. Nambiar S, Laessig K, Toerner J, Farley J, Cox E. Antibacterial drug development: challenges, recent developments, and future considerations. Clin Pharmacol Ther 2014; 96:147-9.
10. Spellberg B, Brass EP, Bradley JS, et al. 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.
11. Workshop Participants. Facilitating antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. 2016. hhttp://www.fda.gov/Drugs/NewsEvents/ucm497650.htm. Accessed 15 November 2016.
12. Rex JH, Eisenstein BI, Alder J, et al. A comprehensive regulatory framework to address the unmet need for new antibacterial treatments. Lancet Infect Dis 2013; 13:269-75.
13. Caliendo AM, Gilbert DN, Ginocchio CC, et al; Infectious Diseases Society of America (IDSA). Better tests, better care: improved diagnostics for infectious diseases. Clin Infect Dis 2013; 57(suppl 3):S139-70.
14. Barlam TF, Cosgrove SE, Abbo LM, et al. Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis 2016; 62:e51-77.
15. Tamma PD, Cosgrove SE, Maragakis LL. Combination therapy for treatment of infections with gram-negative bacteria. Clin Microbiol Rev 2012; 25:450-70.
16. Streptomycin in Tuberculosis Trials Committee. Streptomycin treatment of pulmonary tuberculosis: A medical research council investigation. Br Med J 1948; 2:769.
17. Stolberg HO, Norman G, Trop I. Randomized controlled trials. AJR Am J Roentgenol 2004; 183:1539-44.
18. Casadevall A, Fang FC. Reproducible science. Infect Immun 2010; 78:4972-5.
19. Peck CC, Rubin DB, Sheiner LB. Hypothesis: A single clinical trial plus causal evidence of effectiveness is sufficient for drug approval. Clin Pharmacol Ther 2003; 73:481-90.
20. EUCAST. MIC distributions and ECOFFs. 2016. www.eucast.org/mic-distributions-and-ecoffs/. Accessed 25 July 2016.
21. Louie A, Liu W, Fikes S, Brown D, Drusano GL. Impact of meropenem in combination with tobramycin in a murine model of Pseudomonas aeruginosa pneumonia. Antimicrob Agents Chemother 2013; 57:2788-92.
22. Mattioli F, Fucile C, Del Bono V, et al. Population pharmacokinetics and probability of target attainment of meropenem in critically ill patients. Eur J Clin Pharmacol 2016; 72:839-48.
23. Lodise TP, Sorgel F, Melnick D, Mason B, Kinzig M, Drusano GL. Penetration of meropenem into epithelial lining fluid of patients with ventilator-associated pneumonia. Antimicrob Agents Chemother 2011; 55:1606-10.
24. Craig WA. Pharmacokinetic/pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis 1998; 26:1-10; quiz 11-2.
25. Ambrose PG, Bhavnani SM, Rubino CM, et al. Pharmacokineticspharmacodynamics of antimicrobial therapy: it's not just for mice anymore. Clin Infect Dis 2007; 44:79-86.
26. Jumbe N, Louie A, Leary R, et al. Application of a mathematical model to prevent in vivo amplification of antibiotic-resistant bacterial populations during therapy. J Clin Invest 2003; 112:275-85.
27. Drusano GL. Antimicrobial pharmacodynamics: critical interactions of 'bug and drug'. Nat Rev Microbiol 2004; 2:289-300.
28. Tam VH, Louie A, Deziel MR, Liu W, Leary R, Drusano GL. Bacterial-population responses to drug-selective pressure: examination of garenoxacin's effect on Pseudomonas aeruginosa. J Infect Dis 2005; 192:420-8.
29. Vanscoy B, Mendes RE, Castanheira M, et al. Relationship between ceftolozane-tazobactam exposure and drug resistance amplification in a hollow-fiber infection model. Antimicrob Agents Chemother 2013; 57:4134-8.
30. Andes D, Craig WA. In vivo activities of amoxicillin and amoxicillin-clavulanate against Streptococcus pneumoniae: application to breakpoint determinations. Antimicrob Agents Chemother 1998; 42:2375-9.
31. Drusano GL, Preston SL, Hardalo C, et al. Use of preclinical data for selection of a phase II/III dose for evernimicin and identification of a preclinical MIC breakpoint. Antimicrob Agents Chemother 2001; 45:13-22.
32. Bhavnani SM, Hammel JP, Cirincione BB, Wikler MA, Ambrose PG. Use of pharmacokinetic-pharmacodynamic target attainment analyses to support phase 2 and 3 dosing strategies for doripenem. Antimicrob Agents Chemother 2005; 49:3944-7.
33. Ambrose PG, Forrest A, Craig WA, et al. Pharmacokinetics-pharmacodynamics of gatifloxacin in a lethal murine Bacillus anthracis inhalation infection model. Antimicrob Agents Chemother 2007; 51:4351-5.
34. Ambrose PG. Use of pharmacokinetics and pharmacodynamics in a failure analysis of community-acquired pneumonia: implications for future clinical trial study design. Clin Infect Dis 2008; 47(suppl 3):S225-31.
35. Ambrose PG, Bhavnani SM, Ellis-Grosse EJ, Drusano GL. Pharmacokineticpharmacodynamic considerations in the design of hospital-acquired or ventilator-associated bacterial pneumonia studies: look before you leap! Clin Infect Dis 2010; 51(suppl 1):S103-10.
36. Craig WA. Interrelationship between pharmacokinetics and pharmacodynamics in determining dosage regimens for broad-spectrum cephalosporins. Diagn Microbiol Infect Dis 1995; 22:89-96.
37. Andes D, Craig WA. Pharmacodynamics of the new fluoroquinolone gatifloxacin in murine thigh and lung infection models. Antimicrob Agents Chemother 2002; 46:1665-70.
38. Srivastava S, Modongo C, Siyambalapitiyage Dona CW, Pasipanodya JG, Deshpande D, Gumbo T. Amikacin optimal exposure targets in the hollow-fiber system model of tuberculosis. Antimicrob Agents Chemother 2016; 60:5922-7.
39. Andes D, Craig WA. Treatment of infections with ESBL-producing organisms: pharmacokinetic and pharmacodynamic considerations. Clin Microbiol Infect 2005; 11(suppl 6):10-7.
40. Rodvold KA, Nicolau DP, Lodise TP, et al. Identifying exposure targets for treatment of staphylococcal pneumonia with ceftobiprole. Antimicrob Agents Chemother 2009; 53:3294-301.
41. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: product development under the animal rule. 2015. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm399217.pdf. Accessed 17 November 2016.
42. U.S. Department of Health and Human Services. Non-inferiority clinical trials to establish effectiveness; guidance for industry. 2016. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm202140.pdf. Accessed 28 February 2017.
43. 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.
44. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). 2001. Guidance for industry E 10: choice of control group and related issues in clinical trials. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500002925.pdf. Accessed 16 November 2016.
45. Fava M, Evins AE, Dorer DJ, Schoenfeld DA. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003; 72:115-27.
46. Wellcome Trust. Clinical trial networks for antibiotic development: why they're important and how they should be developed. 2016. https://wellcome.ac.uk/sites/default/files/clinical-trial-networks-for-antibiotic-development-wellcome-oct16.pdf. Accessed 15 November 2015.
47. 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.
48. Cosgrove SE, Hermsen ED, Rybak MJ, et al. Guidance for the knowledge and skills required for antimicrobial stewardship leaders. Infect Control Hosp Epidemiol 2014; 35:1444-51.
49. The Joint Commission. New antimicrobial stewardship standard. 2016. https://www.jointcommission.org/assets/1/6/HAP-CAH-Antimicrobial-Prepub.pdf. Accessed 5 December 2016.
50. Centers for Disease Control and Prevention. Core elements of hospital antibiotic stewardship programs. 2016. http://www.cdc.gov/getsmart/healthcare/implementation/core-elements.html. Accessed 5 December 2016.