Appropriate endpoints for evaluation of new antibiotic therapies for severe infections: a perspective from COMBACTE’s STAT-Net

Author:

Timsit Jean-FrançoisORCID, ,de Kraker Marlieke E. A.,Sommer Harriet,Weiss Emmanuel,Bettiol Esther,Wolkewitz Martin,Nikolakopoulos Stavros,Wilson David,Harbarth Stephan

Funder

IMI-COMBACTE

Deutsche Forschungsgemeinschaft

Publisher

Springer Science and Business Media LLC

Subject

Critical Care and Intensive Care Medicine

Reference44 articles.

1. Muscedere JG, Day A, Heyland DK (2010) Mortality, attributable mortality, and clinical events as end points for clinical trials of ventilator-associated pneumonia and hospital-acquired pneumonia. Clin Infect Dis 51(Suppl 1):S120–S125

2. Talbot GH, Powers JH, Fleming TR, Siuciak JA, Bradley J, Boucher H (2012) Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health. Clin Infect Dis 55:1114–1121

3. Harris PN, McNamara JF, Lye DC, Davis JS, Bernard L, Cheng AC, Doi Y, Fowler VG, Jr., Kaye KS, Leibovici L, Lipman J, Llewelyn MJ, Munoz-Price S, Paul M, Peleg AY, Rodriguez-Bano J, Rogers BA, Seifert H, Thamlikitkul V, Thwaites G, Tong SY, Turnidge J, Utili R, Webb SA, Paterson DL (2016) Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition. Clin Microbiol Infect. doi: 10.1016/j.cmi.2016.10.023

4. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (2014) Guidance for industry hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment. Center for Drug Evaluation and Research, Silver Spring

5. Garrouste Orgeas M, Timsit JF, Soufir L, Tafflet M, Adrie C, Philippart F, Zahar JR, Clec’h C, Goldran-Toledano D, Jamali S, Dumenil AS, Azoulay E, Carlet J (2008) Impact of adverse events on outcomes in intensive care unit patients. Crit Care Med 36:2041–2047

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