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

NCT05060718 | Completed

• 1 other identifier: HONEST-PREPS
• Study Type: observational
• Target: 2,165
• Locations: 7 countries
• Sites: 16

Brief 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.

Conditions

Hospital-acquired Pneumonia; Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (2)

• To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by measuring the timeliness of enrolling eligible patients.

  Assess the proportion of screened, eligible patients at risk of developing HAP or VAP by being enrolled within 48 hours of ICU admission.

  Through study completion, an average of 2 years

• To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by capturing bacterial HAP/VAP episodes.

  Analyse the proportion of enrolled patients who develop HAP/VAP during the initial ICU admission and who are registered in the eCRF (electronic Case Report Form) within 24 hours after onset. Onset is defined as the time of X-ray showing an infiltrate confirming HAP/VAP for patients meeting HAP/VAP FDA criteria.

  Through study completion, an average of 2 years

Secondary Outcomes (12)

• To determine the incidence of HAP/VAP at the ICU.

  From the date of enrolment through to the date of ICU discharge, an average of 11 days

• To determine the implementation of infection prevention and control measures in routine ICU care for prevention of HAP/VAP.

  From the date of enrolment through to the date of ICU discharge, an average of 11 days

• To determine microbiological etiology of HAP/VAP at the ICU (1).

  Between days 7 and 10 after HAP/VAP onset

• To determine microbiological etiology of HAP/VAP at the ICU (2).

  +/- 48 hours of HAP/VAP onset

• To determine microbiological etiology of HAP/VAP at the ICU (3)

  +/- 48 hours of HAP/VAP onset

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an ICU at risk of bacterial HAP/VAP are eligible to participate in the study.

You may qualify if:

• Age \>= 18 years
• At risk of acquiring bacterial HAP or VAP during ICU stay, defined as meeting all of the following criteria:
• expected or documented hospital length of stay of more than 48 hours
• admitted to the ICU

You may not qualify if:

• Death is deemed to be imminent or inevitable during this hospital admission AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment

Sponsors & Collaborators

• UMC Utrecht: lead
• Universiteit Antwerpen: collaborator
• University Hospital, Geneva: collaborator

Study Sites (16)

University Trauma Hospital

Tirana, Albania

Location

Clinical Hospital Center Rijeka

Rijeka, Croatia

Location

General Hospital Dr Josip Bencevic Slavonski Brod

Slavonski Brod, Croatia

Location

Regional Hospital Kolin

Kolín, Czechia

Location

General University Hospital Prague

Prague, Czechia

Location

University Hospital Kralovske Vinohrady

Prague, Czechia

Location

University Hospital Motol

Prague, Czechia

Location

CHU de Limoges

Limoges, France

Location

Liepaja Regional Hospital

Liepāja, Latvia

Location

Paul Stradins Clinical University Hospital

Riga, Latvia

Location

Central Military Emergency University Hospital "Dr. Carol Davila "

Bucharest, Romania

Location

Elias University Emergency Hospital

Bucharest, Romania

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Clinical Center Kragujevac

Kragujevac, Serbia

Location

Clinical Center of Vojvodina

Novi Sad, Serbia

Location

Institute for Pulmonary Diseases of Vojvodina

Novi Sad, Serbia

Location

Related Links

• COMBACTE (COMbatting BACterial resistance in Europe) consortium website: HONEST-PREPS is WP2-4 (Work Package) of COMBACTE-NET

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Bonten, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of molecular epidemiology of infectious diseases, head of department of medical microbiology

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: September 29, 2021
• Study Start: May 20, 2020
• Primary Completion: May 31, 2022
• Study Completion: January 12, 2023
• Last Updated: November 29, 2023

Record last verified: 2022-12

Locations

CR (2); FR (1); RO (2); AL (1); SE (4); CZ (4); LA (2)