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Pneumonia, Ventilator-Associated clinical trials

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NCT ID: NCT05206721 Completed - Clinical trials for Ventilator Associated Pneumonia

Open Suction Circuit Flushing With Chlorhexidine Decreases Ventilator-Associated Pneumonia: A Quasi-experimental Study

Start date: May 10, 2020
Phase: Early Phase 1
Study type: Interventional

Background: Standard practice of flushing saline over the patient's secretions following suctioning is similar to pouring water over grease, leading to motivating bacterial colonization and proliferation inside the suctioning circuit (i.e., catheter, tube, and collecting jar), which can then migrate to patient's lung during suctioning procedure causing ventilator-associated pneumonia (VAP). Therefore, flushing this circuit using an appropriate disinfectant to prevent bacterial colonization inside it and thus decreasing pneumonia occurrence has been our crucial investigation idea. Aim: To investigate the effect of suction system flushing with chlorhexidine (CHX) on the occurrence of VAP among mechanically ventilated patients (MVPs). Design: This study adopted a quasi-experimental research design, and a convenience sampling technique was used to recruit 136 patients to conduct this study. Setting: This study was conducted at surgical intensive care units of Mansoura University Emergency Hospital, Egypt. Results: The intervention group patients had a lower incidence of VAP (by 48.12%) compared with the control group. Moreover, the proposed technique was more effective in decreasing the incidence of late-VAP more than early-VAP. Furthermore, CHX reduced the cost of suction system flushing by 75%. Conclusion: Suction system flushing with CHX can significantly reduce the occurrence of VAP among MVPs and reduce the flushing cost. Therefore, this study recommends incorporating CHX into the daily care of MVPs.

NCT ID: NCT05205525 Completed - Critical Care Clinical Trials

Delayed Antibiotic Therapy in Non-severe Ventilator Acquired Pneumonia (VAP)

DELAVAP
Start date: January 6, 2022
Phase:
Study type: Observational

This retro-prospective monocentric observational study compare the impact of the implementation of a restrictive (delayed) versus aggressive (immediate) antibiotic strategy for Ventilator Acquired Pneumonia suspicion without severity symptoms.

NCT ID: NCT05176353 Completed - Clinical trials for VAP - Ventilator Associated Pneumonia

Ventilator-associated Pneumonia (VAP) Diagnostic Stewardship Trial

Start date: February 11, 2022
Phase: N/A
Study type: Interventional

This is a prospective single-arm pilot/feasibility trial of a bundled diagnostic stewardship intervention at the level of the microbiologic testing pathway in ventilator-associated pneumonia (VAP). The study objectives are to safely and effectively reduce antibiotic overuse and its attendant hazards (adverse drug events, Clostridioides difficile diarrhea and generation of multidrug-resistant organisms) among mechanically-ventilated patients. Participating ICUs will have the following three modifications made in their respiratory culture workflows for mechanically-ventilated patients: 1) providers will be required to select a valid indication for respiratory culture performance (worsening ventilator requirements, purulent sputum production, and/or new radiographic infiltrate on chest imaging); 2) respiratory cultures will be preferentially obtained via bronchoscopic or nonbronchoscopic BAL (by respiratory therapists) rather than via endotracheal aspiration; and 3) BAL samples will be sent for cell count and differentials, and respiratory culture results will not be released for samples with <50% neutrophils. The study will carefully monitor adherence to study interventions, ICU-specific antibiotic utilization rates, and important safety metrics including rates of mortality, ventilator-dependence and ventilator-associated events. The trial hypotheses are: - Implementation of a VAP diagnostic stewardship bundle will be successfully implemented without significant increases in mortality or ventilator-associated events. - Implementation of a VAP diagnostic stewardship bundle will be associated with a reduction in ICU-specific antibiotic utilization rates

NCT ID: NCT05089968 Completed - COVID-19 Clinical Trials

Ventilation Associated Pneumonia and Covid-19

ECOLCOVID
Start date: January 24, 2020
Phase:
Study type: Observational

In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.

NCT ID: NCT05076240 Completed - COVID-19 Clinical Trials

FilmArray® and Management of Ventilator Associated Pneumonia in COVID-19 ARDS

COVIDARRAY
Start date: March 27, 2021
Phase:
Study type: Observational

Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%. VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher. Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients. Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care. New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics. This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period. Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment. The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.

NCT ID: NCT05060718 Completed - Clinical trials for Ventilator Associated Pneumonia

HOspital NEtwork STudy - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies

HONEST-PREPS
Start date: May 20, 2020
Phase:
Study type: Observational

Hospital Acquired and Ventilator Associated Pneumonia (HAP/VAP) pose a significant burden to patients admitted to the Intensive Care Unit (ICU). Reported incidence ranges from 10-16% in all ICU patients (including HAP and VAP) and around 20-30% in ventilated patients (VAP). Patients with HAP/VAP have a high mortality rate. The estimated attributable mortality of VAP is 6-13%. Randomized Controlled Trials (RCTs) are the gold standard for evaluating medical interventions, but are difficult to perform in this population. Several preventive and therapeutic treatment options are being developed that will require evaluation in phase-III trials. These trials are challenging due to the relatively low incidence of the outcome (e.g. HAP/VAP) or of the domain under study (e.g. specific antibiotic resistant infections) and the requirement of informed consent in critically ill patients. There is a need for a well-organized and well-trained international RCT network that enables efficient execution of a series of RCTs in this population. The aim of the current study is to set up an infrastructure to prospectively enroll patients at risk of HAP/VAP in ICUs in several European countries. Site personnel will be trained to obtain a GCP (Good Clinical Practice) certification (if not already done), to timely identify and enroll patients at risk of HAP/VAP, to timely identify occurrence of HAP/VAP, collect informed consent forms, collect source data, enter data into a clinical database, and use a dedicated system to reply to queries. Site sample collection, processing, identifying the causative organism, and antibiotic susceptibility testing will be validated and adapted if required where possible. Where site infrastructure and regulations allow, the possibility of automated data collection of included participants will be explored to ensure sustainability of the future platform. Furthermore, collected data will be used to inform future diagnostic, preventive and therapeutic trials. E.g. they may support assumptions in sample size calculations and expected number of enrolled participants, they may help in prioritizing interventions, or they may be used in simulations of adaptive trials to optimize decision rules.

NCT ID: NCT04911244 Completed - Clinical trials for Ventilator Associated Pneumonia

Diagnostic Modalities for VAP Detection

Start date: August 2016
Phase: N/A
Study type: Interventional

asses diagnostic performance of different methods for detection of ventilator associated pneumonia.

NCT ID: NCT04882085 Completed - Bacteremia Clinical Trials

Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

Start date: August 26, 2021
Phase: Phase 4
Study type: Interventional

This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia [HAP] (including Ventilator-Associated Pneumonia [VAP]); Complicated Urinary-Tract Infection [cUTI]; Complicated Intra-Abdominal Infection [cIAI]; Bloodstream Infection [BSI]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.

NCT ID: NCT04766983 Completed - Covid19 Clinical Trials

Incidence of VAP in Patients With Severe COVID-19

CoV-AP
Start date: February 28, 2020
Phase:
Study type: Observational

Combined retrospective and prospective cohort study to evaluate the incidence of microbiologically confirmed VAP in mechanically ventilated patients with COVID-19. In the retrospective part, microbiological data are based on bi-weekly surveillance ETA. In the prospective part, microbiological data are based on ETA and BAL performed on VAP suspicion. In the prospective part, immunological and virological analyses will be performed on biological samples (blood, respiratory tract) collected from patients at VAP diagnosis.

NCT ID: NCT04755972 Completed - Clinical trials for Corona Virus Infection

Mucolytics in Patients on Invasive Mechanical Ventilation Due to Severe Acute Respiratory Syndrome Coronavirus 2

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

It is planned to include patients over 18 years of age of both sexes, admitted to the Intensive Care Unit of Clinical Hospital Centre Split for respiratory insufficiency caused by severe acute respiratory syndrome coronavirus 2 in need of invasive mechanical ventilation. The patients will be divided into four groups. Group 1 will receive N-acetylcysteine inhalation, Group 2 will receive inhalation with a 5% sodium chloride solution, and Group 3 will receive inhalation of 8.4% sodium bicarbonate, group 4 is a control group and will not routinely receive inhaled mucolytics preventively. All inhalations will be given twice a day 12 hours apart. The first inhalation will be included within 12 hours of the patient being enrolled in the Intensive Care Unit. Patients will be randomized according to the type of inhalation they will receive, randomization will be done by all researchers through the random.org website, and the inhalation will be given by a nurse according to the agreed protocol. RESEARCH GOALS The aim of this study is to determine whether there is a difference in the frequency and duration of ventilator-associated pneumonia (VAP) and whether there is a difference in the number of days spent on mechanical ventilation and in mortality in these four groups of patients. Hypothesis Coronavirus disease 2019 patients on invasive mechanical ventilation and preventive sodium bicarbonate inhalation will have a lower incidence of ventilator-associated pneumonia and fewer days spent on invasive mechanical ventilation than patients inhaled with N-acetylcysteine, 5% saline, or patients without preventive inhalation.