Clinical Trials Logo
  1. Home
  2. Ventilator Associated Pneumonia
  3. NCT05060718

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

Ventilator Associated Pneumonia Clinical Trial

Official title:
HONEST-PREPS: Hospital Network Study - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05060718
Study type Observational
Source UMC Utrecht
Contact
Status Completed
Phase
Start date May 20, 2020
Completion date January 12, 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Not yet recruiting NCT04057625 - Transthoracic Ultrasound in the Diagnosis and Follow-up of Ventilator Associated Pneumonia N/A
Not yet recruiting NCT03267693 - Gastrointestinal Complications in Association With Oropharyngeal and Respiratory Infections in Mechanical Ventilation N/A
Completed NCT00726167 - Serum Procalcitonin Study in the Management of Ventilated Patients N/A
Completed NCT02078999 - Biomarkers in Patients Undergoing Mechanical Ventilation N/A
Recruiting NCT05124977 - Antimicrobial Stewardship For Ventilator Associated Pneumonia in Intensive Care N/A
Recruiting NCT05331885 - A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2 Phase 3
Completed NCT05517759 - Application of VAP Bundle Among ICU Nurses
Active, not recruiting NCT04488510 - Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:
Completed NCT03917888 - Clinical Impact of Lung Ultrasound Monitoring for Diagnosis of VAP N/A
Not yet recruiting NCT06066489 - Effect of Educational Program About Preventive Care Bundle for Prevention of Ventilator Associated Pneumonia Among Newborns N/A
Completed NCT02096328 - Pharmacokinetics, Safety and Efficacy of POL7080 in Patients With Ventilator Associated Pseudomonas Aeruginosa Pneumonia Phase 2
Terminated NCT00771719 - Open Label Pharmacokinetic in Adult Patients With Ventilator-Associated Pneumonia Phase 1
Recruiting NCT05696093 - Efficacy of Cotrimoxazole as a De-escalation Treatment of Ventilator-Associated Pneumonia in Intensive Care Unit Phase 3
Recruiting NCT05354778 - HYDROcortisone Versus Placebo for Severe HospItal-acquired Pneumonia in Intensive Care Patients: the HYDRO-SHIP Study N/A
Not yet recruiting NCT06059040 - Effect of Eliminating Gastric Residual Volume Monitoring on Ventilator Associated Events N/A
Completed NCT04563104 - Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia
Terminated NCT01975350 - Efficacy Study of Colistimethate Sodium Inhalation in Patients With Ventilator-associated Pneumonia
Recruiting NCT06000761 - Frequent Standardized Oral Care Using Human Milk in the Neonatal Intensive Care Unit N/A
Not yet recruiting NCT03294837 - Treatment of Ventilator Associated Pneumonia in Pediatric Intensive Care Unit N/A