Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance

Clinical Infectious Diseases

Volumn 65, Issue 1, 2017, Pages 141-146

  Rex, John H ^a   Talbot, George H ^b   Goldberger, Mark J ^c   Eisenstein, Barry I ^d   Echols, Roger M ^e   Tomayko, John F ^f   Dudley, Michael N ^g   Dane, Aaron ^h  

^a F2G LTD   (United Kingdom)

^b Talbot Advisors LLC   (United States)

^c Mark Goldberger MD MPH LLC   (United States)

^d CARB X   (United States)

^e Infectious Disease Drug Development Consulting LLC   (United States)

^f Drug Product Development   (United States)

^g Medicines Company   (United States)

^h DaneStat Consulting Limited   (United Kingdom)

Author keywords

antibacterial drug development; antimicrobial drug resistance; bacterial resistance; noninferiority trial design

Indexed keywords

ANTIBIOTIC AGENT; COLISTIN; PLAZOMICIN; ANTIINFECTIVE AGENT;

ABDOMINAL INFECTION; ANTIBACTERIAL ACTIVITY; ANTIBIOTIC RESISTANCE; ANTIBIOTIC SENSITIVITY; ANTIBIOTIC THERAPY; ARTICLE; BACTERIAL INFECTION; BACTERIAL PNEUMONIA; CLINICAL DECISION MAKING; CLINICAL PRACTICE; CLINICAL TRIAL (TOPIC); DRUG DESIGN; DRUG EFFICACY; DRUG SAFETY; EPIDEMIC; FOOD AND DRUG ADMINISTRATION; HEALTH CARE QUALITY; HUMAN; IN VITRO STUDY; INFECTION; INFECTION CONTROL; MULTIDRUG RESISTANCE; PHARMACODYNAMICS; PHARMACOKINETIC PARAMETERS; PRACTICE GUIDELINE; PRIORITY JOURNAL; PUBLIC HEALTH; RISK FACTOR; STUDY DESIGN; URINARY TRACT INFECTION; BACTERIUM; DRUG DEVELOPMENT; DRUG EFFECT; MICROBIOLOGY;

ANTI-BACTERIAL AGENTS; BACTERIA; BACTERIAL INFECTIONS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; DRUG RESISTANCE, MULTIPLE, BACTERIAL; HUMANS;

EID: 85021844786     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/cix246     Document Type: Article

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