Executive Summary
o John G. Bartlett,
o Philip S. Barie,
o Michael S. Niederman,
o and Richard G. Wunderink
Workshop on Clinical Trials of Antibacterial Agents for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S1-S3 doi:10.1086/653066
o Brad Spellberg, George Talbot, and for the Infectious Diseases Society of America, American College of Chest Physicians, American Thoracic Society, and Society of Critical Care Medicine
Recommended Design Features of Future Clinical Trials of Antibacterial Agents for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S150-S170 doi:10.1086/653065
o Steven L. Barriere
Challenges in the Design and Conduct of Clinical Trials for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia: An Industry Perspective
Clin Infect Dis. (2010) 51(Supplement 1): S4-S9 doi:10.1086/653033
o David N. Gilbert
Scenario 1: A Patient with Hospital-Acquired Bacterial Pneumonia—Introduction to Clinical Trial Design Issues
Clin Infect Dis. (2010) 51(Supplement 1): S10-S11 doi:10.1086/653034
o Michael S. Niederman
Hospital-Acquired Pneumonia, Health Care-Associated Pneumonia, Ventilator-Associated Pneumonia, and Ventilator-Associated Tracheobronchitis: Definitions and Challenges in Trial Design
Clin Infect Dis. (2010) 51(Supplement 1): S12-S17 doi:10.1086/653035
o John H. Powers
Recommendations for Improving the Design, Conduct, and Analysis of Clinical Trials in Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S18-S28 doi:10.1086/653036
o Marin H. Kollef
Review of Recent Clinical Trials of Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia: A Perspective from Academia
Clin Infect Dis. (2010) 51(Supplement 1): S29-S35 doi:10.1086/653037
o Alfred Sorbello,
o Scott Komo,
o Thamban Valappil,
o and Sumati Nambiar
Registration Trials of Antibacterial Drugs for the Treatment of Nosocomial Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S36-S41 doi:10.1086/653038
o Thomas M. File, Jr.
Recommendations for Treatment of Hospital-Acquired and Ventilator-Associated Pneumonia: Review of Recent International Guidelines
Clin Infect Dis. (2010) 51(Supplement 1): S42-S47 doi:10.1086/653048
o Antoni Torres,
o Miquel Ferrer,
o and Joan Ramón Badia
Treatment Guidelines and Outcomes of Hospital-Acquired and Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S48-S53 doi:10.1086/653049
o Jean Chastre and
o Charles-Edouard Luyt
Other Therapeutic Modalities and Practices: Implications for Clinical Trials of Hospital-Acquired or Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S54-S58 doi:10.1086/653050
o Donald E. Craven and
o Karin I. Hjalmarson
Ventilator-Associated Tracheobronchitis and Pneumonia: Thinking Outside the Box
Clin Infect Dis. (2010) 51(Supplement 1): S59-S66 doi:10.1086/653051
o Lena M. Napolitano
Use of Severity Scoring and Stratification Factors in Clinical Trials of Hospital-Acquired and Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S67-S80 doi:10.1086/653052
o Ronald N. Jones
Microbial Etiologies of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S81-S87 doi:10.1086/653053
o Jean Chastre,
o Jean-Louis Trouillet,
o Alain Combes,
o and Charles-Edouard Luyt
Diagnostic Techniques and Procedures for Establishing the Microbial Etiology of Ventilator-Associated Pneumonia for Clinical Trials: The Pros for Quantitative Cultures
Clin Infect Dis. (2010) 51(Supplement 1): S88-S92 doi:10.1086/653054
o Michael S. Niederman
The Argument against Using Quantitative Cultures in Clinical Trials and for the Management of Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S93-S99 doi:10.1086/653055
o David N. Gilbert
Scenario 2: A Patient with Ventilator-Associated Bacterial Pneumonia—Introduction to Clinical Trial Design Issues
Clin Infect Dis. (2010) 51(Supplement 1): S100-S102 doi:10.1086/653056
o Paul G. Ambrose,
o Sujata M. Bhavnani,
o Evelyn J. Ellis Grosse,
o and George L. Drusano
Pharmacokinetic-Pharmacodynamic Considerations in the Design of Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia Studies: Look before You Leap!
Clin Infect Dis. (2010) 51(Supplement 1): S103-S110 doi:10.1086/653057
o Cynthia F. Kleppinger and
o Leslie K. Ball
Building Quality in Clinical Trials With Use of a Quality Systems Approach
Clin Infect Dis. (2010) 51(Supplement 1): S111-S116 doi:10.1086/653058
o Katherine A. Laessig
End Points in Hospital-Acquired Pneumonia and/or Ventilator-Associated Pneumonia Clinical Trials: Food and Drug Administration Perspective
Clin Infect Dis. (2010) 51(Supplement 1): S117-S119 doi:10.1086/653059
o John G. Muscedere,
o Andrew Day,
o and Daren K. Heyland1
Mortality, Attributable Mortality, and Clinical Events as End Points for Clinical Trials of Ventilator-Associated Pneumonia and Hospital-Acquired Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S120-S125 doi:10.1086/653060
o Richard G. Wunderink
Surrogate Markers and Microbiologic End Points
Clin Infect Dis. (2010) 51(Supplement 1): S126-S130 doi:10.1086/653061
o Marya D. Zilberberg and
o Andrew F. Shorr
Ventilator-Associated Pneumonia: The Clinical Pulmonary Infection Score as a Surrogate for Diagnostics and Outcome
Clin Infect Dis. (2010) 51(Supplement 1): S131-S135 doi:10.1086/653062
o John S. Bradley
Considerations Unique to Pediatrics for Clinical Trial Design in Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S136-S143 doi:10.1086/653063
o George H. Talbot
Considerations in Undertaking a Clinical Development Program for Hospital-Acquired Bacterial Pneumonia and/or Ventilator-Associated Bacterial Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S144-S149 doi:10.1086/653064
o John G. Bartlett,
o Richard G. Wunderink,
o Michael S. Niederman,
o and Philip S. Barie
Workshop on Issues in the Design of Clinical Trials for Antibacterial Drugs for Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia
Clin Infect Dis. (2010) 51(Supplement 1): S171 doi:10.1086/653067
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