Response to Spellberg and Brass

Clinical Infectious Diseases

Volumn 62, Issue 4, 2015, Pages 526-

  Solomkin, Joseph S ^a   Hershberger, Ellie ^b   Eckmann, Christian ^c  

^a UNIVERSITY OF CINCINNATI COLLEGE OF MEDICINE   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Department of General   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

CEFTOLOZANE PLUS TAZOBACTAM; EXTENDED SPECTRUM BETA LACTAMASE; MEROPENEM; METRONIDAZOLE; ANTIINFECTIVE AGENT; CEPHALOSPORIN DERIVATIVE; PENICILLANIC ACID;

ABDOMINAL INFECTION; ANTIBACTERIAL ACTIVITY; ANTIBIOTIC THERAPY; ANTIMICROBIAL THERAPY; CLINICAL PRACTICE; CLINICAL PROTOCOL; EUROPEAN MEDICINES AGENCY; FOOD AND DRUG ADMINISTRATION; HUMAN; INTENTION TO TREAT ANALYSIS; LETTER; MORTALITY; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PSEUDOMONAS AERUGINOSA; UNITED STATES; ANALOGS AND DERIVATIVES; BACTERIAL INFECTIONS; FEMALE; INTRAABDOMINAL INFECTIONS; MALE; MULTIDRUG RESISTANCE;

ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; CEPHALOSPORINS; DRUG RESISTANCE, MULTIPLE, BACTERIAL; FEMALE; HUMANS; INTRAABDOMINAL INFECTIONS; MALE; METRONIDAZOLE; PENICILLANIC ACID;

EID: 85003055036     PISSN: 10584838     EISSN: 15376591     Source Type: Journal    
DOI: 10.1093/cid/civ896     Document Type: Letter

References (7)

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2. US Department of Health and Human Services. Food and Drug Administration. Guidance for Industry. Complicated intra-abdominal infections: developing drugs for treatment. September 2012.
3. Committee for Medicinal Products for Human Use. Addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 REV 2) to address indication-specific clinical data. EMA/CHMP/ 776609/2011. 2012.
4. Spellberg B, Brass EP. Noninferiority doesn't mean not inferior. Clin Infect Dis 2016; 62:525-6.
5. Ertapenem Drug Approval Package. Center for Drug Evaluation and Research. Available at: http://www. accessdata.fda.gov/drugsatfda-docs/nda/2001/21337- Invanz.cfm. Accessed 22 September 2015.
6. Doripenem Drug Approval Package. Center for Drug Evaluation and Research. Available at: http://www. accessdata.fda.gov/drugsatfda-docs/nda/2007/022106 TOC.cfm. Accessed 22 September 2015.
7. Solomkin JS, Ristagno RL, Das AF, et al. Source control review in clinical trials of anti-infective agents in complicated intra-abdominal infections. Clin Infect Dis 2013; 56:1765-73.