EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics
NCT05979545
Blood Stream Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Kuala Lumpur, Malaysia
View Trial DetailsNCT Number: NCT05719259
Ventilator-Associated Pneumonia (VAP) is a bacterial respiratory infection that patients in the Intensive Care Unit (ICU) often get when they cannot breathe for themselves and require mechanical ventilation. It is linked to higher chances of death, a longer stay in the hospital, higher costs, and the use of more antibiotics.
Options to help prevent or treat this disease are in development and will require evaluation in future clinical trials.
The goal of POS-VAP is to build and continuously train a network of ICUs to be prepared for doing these trials, to facilitate their execution.
Interested in participating?
Request Info18 year and older
All sexes
Observational
University Hospital of Trauma, Tirana, Albania
Ventilator associated pneumonia (VAP) is one of the most frequent healthcare associated infections in the Intensive Care Unit (ICU) and a significant burden among ICU patients under invasive mechanical ventilation (IMV).
Several preventive and therapeutic treatment options are being developed in the field of VAP that will require evaluation in future randomized controlled trials (RCTs).
RCTs are the gold standard for evaluating medical interventions but are difficult to perform in a population at risk of, or with, VAP.
These trials are challenging since it is difficult to recruit a large enough volume of high-quality centers to achieve the required number of recruited patients, especially if the focus is on specific patient groups (e.g., VAP due to a specific pathogen), for which site selection can be even more challenging and time consuming. There is a need for a well-organized and well-trained international network of ICUs focusing on VAP research that enables efficient execution of RCTs on diagnostic, preventive and curative interventions in this population.
Through a Perpetual Observational Study (POS) we can provide quick access to a network of sites that fulfill pre-specified criteria. Additionally, the structured network of POS sites within ECRAID will maintain continuous activity to carry out observational studies in this specific field, implementing informed consent (where required), increasing quality and efficiency, and facilitating contracting.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 4 years
POS-VAP' overarching objective is to build a sustainable European clinical research network of ICUs that serves as platform to facilitate observational and randomized VAP research activities.
This objective will be measured by in three ways:
Time frame: 4 years
Time frame: 4 years
Time frame: 4 years
Average proportion of sites actively recruiting for at least one embedded study at any time during the study period, overall and stratified by observational and interventional embedded studies.
Time frame: 4 years
Proportion (%) of POS-VAP enrolled population included in an embedded preventive study, stratified by observational and interventional embedded studies.
Time frame: 4 years
Proportion (%) of POS-VAP enrolled population included in an embedded diagnostic study, stratified by observational and interventional embedded studies.
Time frame: 4 years
Proportion (%) of POS-VAP VAP population enrolled in at least one embedded treatment study with clinical outcome after VAP as endpoint, stratified by observational and interventional embedded studies.
Time frame: 4 years
Incidence of VAP per 1000 ventilation days, measured among the Enrolled population, overal and per site
Time frame: 4 years
ICU mortality, measured among the Enrolled population not developping VAP, overal and per site
Time frame: 4 years
Time from start of invasive mechanical ventilation (IMV) until VAP diagnosis (days), measured among the VAP population, overall and per site
Time frame: 4 years
Time under IMV after VAP diagnosis (days), measured among the VAP population, measured overall and per site
Time frame: 4 years
IMV-free days from VAP diagnosis till day 28 after VAP diagnosis (days), measured among the VAP population, overall and per site
Time frame: 4 years
Length of ICU stay after VAP diagnosis (days), measured among the VAP population, overall and per site
Time frame: 4 years
All-cause mortality at day 28 after VAP diagnosis (%), measured among the VAP population, overall and per site
Time frame: 4 years
Mortality rate at ICU discharge, measured among the VAP population, overall and per site
Time frame: 4 years
Resolution of signs and symptoms of VAP between days 7 and 10 from VAP diagnosis (%), measured among the VAP population, overall and per site
Contact information is provided by the study sponsor or research team.
Ana HERNANDEZ, MD, PhD
CONTACT
Bruno FRANCOIS, MD
CONTACT
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Other
POS-VAP: Perpetual Observational Study - Ventilator Associated Pneumonia
Acronym: POS-VAP
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05979545
Blood Stream Infections, Carbapenem-Resistant Enterobacteriaceae Infection
Kuala Lumpur, Malaysia
View Trial DetailsNCT05671328
Aspergillosis, Bacterial Infections and Mycoses
Lille, France
View Trial DetailsNCT05485051
Catheter-Associated Urinary Tract Infection, Central Line-associated Bloodstream Infection (CLABSI)
Colatina, Espírito Santo, Brazil
View Trial DetailsNCT03506113
Cross Infection, Disease Attributes
Nagoya, Aichi-ken, Japan
View Trial Details