scholarly journals Trends in hospital-acquired and ventilator-associated bacterial pneumonia trials

2020 ◽  
Author(s):  
Stephen M Bart ◽  
Daniel Rubin ◽  
Peter Kim ◽  
John J Farley ◽  
Sumathi Nambiar
Keyword(s):  
Drug Therapy ◽  
Drug Development ◽  
Bacterial Pneumonia ◽  
Asia Pacific ◽  
Multivariate Logistic Regression Model ◽  
Chronic Obstructive ◽  
Antibacterial Drug ◽  
Eastern European ◽  
The Mean ◽  
Hospital Acquired

Abstract Background New drug development for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) is critical. Challenges remain in the conduct of HABP/VABP trials, especially in the contexts of enrollment, endpoints, non-study antibacterial drug therapy, and antimicrobial resistance. Methods Four Phase 3 noninferiority trials (n=2,433 participants) submitted to the Food and Drug Administration after 2015 were analyzed for enrollment statistics, participant characteristics associated with 28-day all-cause mortality (ACM), microbiology, and receipt of non-study antibacterial drugs. All trials primarily enrolled patients with gram-negative bacterial infections. Results The mean trial length was 2.7 years and the mean recruitment rate was 0.17 participants/site/month. ACM at 28 days was 17.1% and was higher among participants diagnosed with ventilated HABP (31.9%) or VABP (19.0%) than non-ventilated HABP (9.9%). VABP participants tended to be younger, less likely to have chronic obstructive pulmonary disease, and more likely to have previously sustained an injury. Age, South American residence, diagnosis of ventilated HABP or VABP, and Acinetobacter baumannii infection were all associated with 28-day ACM in a multivariate logistic regression model. A. baumannii infection was most common in Eastern European and Asia/Pacific participants, and Eastern European isolates exhibited the highest levels of meropenem resistance. Concomitant non-study antibacterial drug therapy most commonly included beta-lactams and was initiated earliest in Western Europe. Conclusion This analysis of recent trials may assist in trial considerations for HABP/VABP development programs and promote needed antibacterial drug development for patients with serious infections.

Concordance of Early and Late End Points for Community-acquired Bacterial Pneumonia Trials

2020 ◽  
Author(s):  
Stephen M Bart ◽  
Sumathi Nambiar ◽  
Ramya Gopinath ◽  
Daniel Rubin ◽  
John J Farley
Keyword(s):  
Logistic Regression ◽  
Drug Therapy ◽  
Bacterial Pneumonia ◽  
Early Time ◽  
Antibacterial Drug ◽  
Multivariate Logistic Regression ◽  
End Points ◽  
End Point ◽  
Regulatory Convergence ◽  
Time Point

Abstract Background While there are ongoing regulatory convergence efforts, differences remain in primary end points recommended for community-acquired bacterial pneumonia (CABP) trials. The US Food and Drug Administration (FDA) recommends assessing CABP symptom resolution at an early time point (3–5 days after randomization). Other regulatory agencies recommend assessing overall clinical response at a later time point (5–10 days after therapy ends). Methods We analyzed participant-level data from 6 recent CABP trials submitted to the FDA (n = 4645 participants) to evaluate concordance between early and late end-point outcomes. We used multivariate logistic regression to identify factors associated with discordance. Results Early and late end-point outcomes were concordant for 85.6% of participants. The proportions of early end-point responders that ultimately failed and early end-point nonresponders that ultimately succeeded were similar (6.0% vs 8.4%, respectively). Early end-point response was highly predictive of late end-point success (positive predictive value, 92.9%). Multivariate logistic regression identified early end-point responders/late end-point failures as less likely to be obese and more likely to be infected with Chlamydophila pneumoniae or Staphylococcus aureus, have received antibacterial drug therapy prior to randomization, and have severe chest pain at baseline. The most common investigator-provided reasons for failure among early end-point responders/late end-point failures were receipt of nonstudy antibacterial drug therapy and loss to follow-up. Conclusions Early and late end-point outcomes were highly concordant. These data may be useful in the continuing efforts to reach international regulatory convergence on CABP clinical trial design recommendations.

scholarly journals Characteristics and outcomes in acute patients receiving mechanical ventilation in a Coronary Care Unit (CCU)

2021 ◽  
Vol 10 (Supplement_1) ◽  
Author(s):  
M Rivadeneira Ruiz ◽  
DF Arroyo Monino ◽  
T Seoane Garcia ◽  
MP Ruiz Garcia ◽  
JC Garcia Rubira
Keyword(s):  
Mechanical Ventilation ◽  
Cardiac Arrest ◽  
Hospital Mortality ◽  
Coronary Care Unit ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Funding Sources ◽  
Copd Patients ◽  
The Mean ◽  
Coronary Care

Abstract Funding Acknowledgements Type of funding sources: None. Objectives Mechanical ventilation is the short-term technical support most widely used and cardiac arrest its main indication in a Coronary Care Unit (CCU). However, the knowledge about the specific moment and ventilator mode of onset to avoid the acute lung injury is still equivocal. Our objective is to determine the survival rate and the prognostic factors in patients supported by mechanical ventilation. Methods We conducted a retrospective cohort study of adult patients admitted to the CCU between January 2018 and November 2020 that received mechanical ventilation during the hospital stay. Results We collected 94 patients, 28% females with a median age of 68 ± 11,9. 43% were diabetics and almost one quarter of them had some degree of chronic obstructive pulmonary disease (COPD). Ischemic cardiopathy (33%) and heart failure (31%) were frequent pathologies as well as renal injury (29% patients a filtration rate below 45 mL/min/1,73m2). The reason for initiating mechanical ventilation was cardiac arrest in the half of the patients. Volume-controlled ventilation (73%) was the initial setting mode in most cases. The support with vasoactive drugs were highly necessary in these patients (Infection rate of 48%). In the subgroup analysis, we realized that the number of reintubations and the necessity of non-invasive ventilation were higher in the COPD group (p = 0,01), as well as tracheostomy (p = 0,03). COPD patients also needed higher maintaining PEEP, though this was not statistically significant. The mean length of stay in the intensive care unit of our cohort was 11 days (range: 1-78 days; median: 8 days) and the mean length of mechanical ventilation 6 days (range: 1-64 days; median: 3 days). The in-hospital mortality was 41,4%. Conclusions Cardiac arrest is the most common reason of mechanical ventilation support. Our study showed that COPD patients presented more complications during the weaning and the period after extubation. In-hospital mortality remains high in intubated patients.

scholarly journals COPD Guidelines in the Asia-Pacific Regions: Similarities and Differences

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1153
Author(s):  
Shih-Lung Cheng ◽  
Ching-Hsiung Lin
Keyword(s):  
Chronic Obstructive Pulmonary Disease ◽  
Pulmonary Disease ◽  
Global Strategy ◽  
Airflow Limitation ◽  
Asia Pacific ◽  
Pharmacologic Therapy ◽  
Chronic Obstructive ◽  
Obstructive Pulmonary Disease ◽  
Country Level ◽  
Similarities And Differences

Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease that is associated with significant morbidity and mortality, giving rise to an enormous social and economic burden. The Global Strategy for the Diagnosis, Management and Prevention of Chronic Obstructive Pulmonary Disease (GOLD) report is one of the most frequently used documents for managing COPD patients worldwide. A survey was conducted across country-level members of Asia-Pacific Society of Respiratory (APSR) for collecting an updated version of local COPD guidelines, which were implemented in each country. This is the first report to summarize the similarities and differences among the COPD guidelines across the Asia-Pacific region. The degree of airflow limitation, assessment of COPD severity, management, and pharmacologic therapy of stable COPD will be reviewed in this report.

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.

scholarly journals Well-Being of Healthcare Workers and the General Public during the COVID-19 Pandemic in Vietnam: An Online Survey

2021 ◽  
Vol 18 (9) ◽  
pp. 4737
Author(s):  
Tuyen Dinh Hoang ◽  
Robert Colebunders ◽  
Joseph Nelson Siewe Fodjo ◽  
Nhan Phuc Thanh Nguyen ◽  
Trung Dinh Tran ◽  
...  
Keyword(s):  
Healthcare Workers ◽  
Large Scale ◽  
Online Survey ◽  
Preventive Measures ◽  
Vaccine Coverage ◽  
Health Sector ◽  
Well Being ◽  
Multivariate Logistic Regression Model ◽  
The Mean ◽  
Restrictive Measures

The COVID-19 pandemic and associated restrictive measures implemented may considerably affect people’s lives. This study aimed to assess the well-being of Vietnamese people after COVID-19 lockdown measures were lifted and life gradually returned to normal. An online survey was organized from 21 to 25 April 2020 among Vietnamese residents aged 18 and over. The survey was launched by the Hue University of Medicine and Pharmacy. The WHO-5 Well-Being Index (scored 0–25) was used to score participants’ well-being. A multivariate logistic regression model was used to determine the predictors of well-being. A total of 1922 responses were analyzed (mean age: 31 years; 30.5% male; 88.2% health professionals or students in the health sector). The mean well-being score was 17.35 ± 4.97. Determinants of a high well-being score (≥13) included older age, eating healthy food, practicing physical exercise, working from home, and adhering to the COVID-19 preventive measures. Female participants, persons worried about their relatives’ health, and smokers were more likely to have a low well-being score. In conclusion, after the lockdown measures were lifted, the Vietnamese have people continued to follow COVID-19 preventive measures, and most of them scored high on the well-being scale. Waiting to achieve large-scale COVID-19 vaccine coverage, promoting preventive COVID-19 measures remains important, together with strategies to guarantee the well-being of the Vietnamese people.

scholarly journals MODERN APPROACHES TO TREATMENT OF PSEUDOMONAS AERUGINOSA VENTILATOR-ASSOCIATED PNEUMONIA (LITERATURE REVIEW)

2019 ◽  
Vol 72 (5) ◽  
pp. 892-896
Author(s):  
Olha A. Poda ◽  
Tetyana O. Kryuchko ◽  
Inna N. Nesina ◽  
Olha Ya. Tkachenko ◽  
Nataliia V. Kuzmenko
Keyword(s):  
Pseudomonas Aeruginosa ◽  
Causative Agent ◽  
Optimal Dose ◽  
Correct Choice ◽  
Antibacterial Drug ◽  
Controversial Issues ◽  
Ventilator Associated Pneumonia ◽  
Scientific Investigations ◽  
Multiresistant Strains ◽  
Hospital Acquired

Introduction: Nowadays anti-microbial therapy of ventilator-associated pneumonia caused by is one of the most topical issue as a consequence of widespread multiresistant strains of causative agent and their biological peculiarity of actively formation of resistance to new antibacterial drugs. The aim is to describe modern approaches to therapy of ventilator-associated pneumonia causative agent of which is presented by Pseudomonas aureginosa . Materials and methods: An analysis and summing up of results of scientific investigations described in medical publications concerning the issues of therapy of ventilatorassociated pneumonia caused by Pseudomonas aureginosa was done. Conclusions: Despite the development of modern approaches to anti-microbial therapy of ventilator-associated pneumonia caused by Pseudomonas aeruginosa, which are also concerned with such controversial issues as correct choice of antibacterial drug, its optimal dose, and duration of this therapy, the problem of treatment of hospital-acquired infections of respiratory airways caused by Pseudomonas aeruginosa has been discussable yet and requires the further study.

Sign in / Sign up

Export Citation Format

Share Document