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White Paper: Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-Spectrum Indications, and Unmet Needs.
Boucher, Helen W; Ambrose, Paul G; Chambers, H F; Ebright, Richard H; Jezek, Amanda; Murray, Barbara E; Newland, Jason G; Ostrowsky, Belinda; Rex, John H.
Afiliação
  • Boucher HW; Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine.
  • Ambrose PG; Institute for Clinical Pharmacodynamics, Schenectady.
  • Chambers HF; University of California at San Francisco.
  • Ebright RH; Rutgers University, Piscataway, New Jersey.
  • Jezek A; Infectious Diseases Society of America, Arlington, Virginia.
  • Murray BE; Division of Infectious Diseases, University of Texas Medical School at Houston.
  • Newland JG; St Louis Children's Hospital, Missouri.
  • Ostrowsky B; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
  • Rex JH; CARB-X, Boston, Massachusetts.
J Infect Dis ; 216(2): 228-236, 2017 07 15.
Article em En | MEDLINE | ID: mdl-28475768
Despite progress in antimicrobial drug development, a critical need persists for new, feasible pathways to develop antibacterial agents to treat people infected with drug-resistant bacteria. Infections due to resistant gram-negative bacilli continue to cause unacceptable morbidity and mortality rates. Antibacterial agents have been historically studied in noninferiority clinical trials that focus on a single site of infection (eg, complicated urinary tract infections, intra-abdominal infections), yet these designs may not be optimal, and often are not feasible, for study of infections caused by drug-resistant bacteria. Over the past several years, multiple stakeholders have worked to develop consensus regarding paths forward with a goal of facilitating timely conduct of antimicrobial development. Here we advocate for a novel and pragmatic approach and, toward this end, present feasible trial designs for antibacterial agents that could enable conduct of narrow-spectrum, organism-specific clinical trials and ultimately approval of critically needed new antibacterial agents.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Farmacorresistência Bacteriana Múltipla / Descoberta de Drogas / Bactérias Gram-Negativas / Antibacterianos Tipo de estudo: Clinical_trials Limite: Animals / Humans Idioma: En Revista: J Infect Dis Ano de publicação: 2017 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Farmacorresistência Bacteriana Múltipla / Descoberta de Drogas / Bactérias Gram-Negativas / Antibacterianos Tipo de estudo: Clinical_trials Limite: Animals / Humans Idioma: En Revista: J Infect Dis Ano de publicação: 2017 Tipo de documento: Article