scholarly journals Recommended Design Features of Future Clinical Trials of Antibacterial Agents for Hospital‐Acquired Bacterial Pneumonia and Ventilator‐Associated Bacterial Pneumonia

2010 ◽  
Vol 51 (S1) ◽  
pp. S150-S170 ◽  
Author(s):  
Brad Spellberg ◽  
George Talbot
Keyword(s):  
Clinical Trials ◽  
Bacterial Pneumonia ◽  
Antibacterial Agents ◽  
Design Features ◽  
Hospital Acquired

scholarly journals Design of clinical trials of antibacterial agents for community-acquired bacterial pneumonia

2011 ◽  
Vol 1 (1) ◽  
pp. 19-32 ◽  
Author(s):  
Brad Spellberg ◽  
Roger J Lewis ◽  
Helen W Boucher ◽  
Eric P Brass
Keyword(s):  
Clinical Trials ◽  
Bacterial Pneumonia ◽  
Antibacterial Agents

scholarly journals Cost Drivers of Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia Phase Three Clinical Trials

2015 ◽  
Vol 2 (suppl_1) ◽  
Author(s):  
Stella Stergiopoulos ◽  
Pamela Tenaerts ◽  
Kenneth Getz ◽  
Carrie Brown ◽  
Josephine Awatin ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Bacterial Pneumonia ◽  
Cost Drivers ◽  
Hospital Acquired

scholarly journals Elaboration of Consensus Clinical Endpoints to Evaluate Antimicrobial Treatment Efficacy in Future Hospital-acquired/Ventilator-associated Bacterial Pneumonia Clinical Trials

2019 ◽  
Vol 69 (11) ◽  
pp. 1912-1918 ◽  
Author(s):  
Emmanuel Weiss ◽  
Jean-Ralph Zahar ◽  
Jeff Alder ◽  
Karim Asehnoune ◽  
Matteo Bassetti ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Clinical Trials ◽  
Treatment Efficacy ◽  
Clinical Cure ◽  
Bacterial Pneumonia ◽  
Randomized Clinical Trials ◽  
Signs And Symptoms ◽  
Antimicrobial Treatment ◽  
Clinical Endpoints ◽  
Hospital Acquired

Abstract Background Randomized clinical trials (RCTs) in hospital-acquired and ventilator-associated bacterial pneumonia (HABP and VABP, respectively) are important for the evaluation of new antimicrobials. However, the heterogeneity in endpoints used in RCTs evaluating treatment of HABP/VABP may puzzle clinicians. The aim of this work was to reach a consensus on clinical endpoints to consider in future clinical trials evaluating antimicrobial treatment efficacy for HABP/VABP. Methods Twenty-six international experts from intensive care, infectious diseases, and the pharmaceutical industry were polled using the Delphi method. Results The panel recommended a hierarchical composite endpoint including, by priority order, (1) survival at day 28, (2) mechanical ventilation–free days through day 28, and (3) clinical cure between study days 7 and 10 for VABP; and (1) survival (day 28) and (2) clinical cure (days 7–10) for HABP. Clinical cure was defined as the combination of resolution of signs and symptoms present at enrollment and improvement or lack of progression of radiological signs. More than 70% of the experts agreed to assess survival and mechanical ventilation–free days though day 28, and clinical cure between day 7 and day 10 after treatment initiation. Finally, the hierarchical order of endpoint components was reached after 3 Delphi rounds (72% agreement). Conclusions We provide a multinational expert consensus on separate hierarchical composite endpoints for VABP and HABP, and on a definition of clinical cure that could be considered for use in future HABP/VABP clinical trials.

scholarly journals Workshop on Clinical Trials of Antibacterial Agents for Hospital‐Acquired Pneumonia and Ventilator‐Associated Pneumonia

2010 ◽  
Vol 51 (S1) ◽  
pp. S1-S3 ◽  
Author(s):  
John G. Bartlett ◽  
Philip S. Barie ◽  
Michael S. Niederman ◽  
Richard G. Wunderink
Keyword(s):  
Clinical Trials ◽  
Antibacterial Agents ◽  
Ventilator Associated Pneumonia ◽  
Hospital Acquired Pneumonia ◽  
Hospital Acquired

scholarly journals A Phase 3, Randomized, Double-Blind Study Comparing Tedizolid Phosphate and Linezolid for Treatment of Ventilated Gram-Positive Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia

2021 ◽  
Author(s):  
Richard G Wunderink ◽  
Antoine Roquilly ◽  
Martin Croce ◽  
Daniel Rodriguez Gonzalez ◽  
Satoshi Fujimi ◽  
...  
Keyword(s):  
Clinical Response ◽  
Bacterial Pneumonia ◽  
Double Blind Study ◽  
Phase 3 ◽  
Gram Positive ◽  
Double Blind ◽  
Intention To Treat ◽  
The Difference ◽  
Hospital Acquired ◽  
Noninferiority Margin

Abstract Background Hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) are associated with high mortality rates. We evaluated the efficacy and safety of tedizolid (administered as tedizolid phosphate) for treatment of gram-positive ventilated HABP/VABP. Methods In this randomized, noninferiority, double-blind, double-dummy, global phase 3 trial, patients were randomized 1:1 to receive intravenous tedizolid phosphate 200 mg once daily for 7 days or intravenous linezolid 600 mg every 12 hours for 10 days. Treatment was 14 days in patients with concurrent gram-positive bacteremia. The primary efficacy end points were day 28 all-cause mortality (ACM; noninferiority margin, 10%) and investigator-assessed clinical response at test of cure (TOC; noninferiority margin, 12.5%) in the intention-to-treat population. Results Overall, 726 patients were randomized (tedizolid, n = 366; linezolid, n = 360). Baseline characteristics, including incidence of methicillin-resistant Staphylococcus aureus (31.3% overall), were well balanced. Tedizolid was noninferior to linezolid for day 28 ACM rate: 28.1% and 26.4%, respectively (difference, –1.8%; 95% confidence interval [CI]: –8.2 to 4.7). Noninferiority of tedizolid was not demonstrated for investigator-assessed clinical cure at TOC (tedizolid, 56.3% vs linezolid, 63.9%; difference, –7.6%; 97.5% CI: –15.7 to 0.5). In post hoc analyses, no single factor accounted for the difference in clinical response between treatment groups. Drug-related adverse events occurred in 8.1% and 11.9% of patients who received tedizolid and linezolid, respectively. Conclusions Tedizolid was noninferior to linezolid for day 28 ACM in the treatment of gram-positive ventilated HABP/VABP. Noninferiority of tedizolid for investigator-assessed clinical response at TOC was not demonstrated. Both drugs were well tolerated. Clinical Trials Registration NCT02019420.

The Programmable Implantable Medication System (PIMS): Design Features and Pre-Clinical Trials

1990 ◽  
Vol 22 (04) ◽  
pp. 201-206 ◽  
Author(s):  
C. Saudek ◽  
R. Fischell ◽  
M. Swindle
Keyword(s):  
Clinical Trials ◽  
Design Features
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