Clinical trial NCT05060718: HOspital NEtwork STudy - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies
Official title: HONEST-PREPS: Hospital Network Study - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital-acquired Pneumonia
Ventilator Associated Pneumonia
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: University Hospital, Geneva
First posted: 2021-09-29
Enrollment: 2165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by measuring the timeliness of enrolling eligible patients.
timeFrame: Through study completion, an average of 2 years
measure: To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by capturing bacterial HAP/VAP episodes.
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: To determine the incidence of HAP/VAP at the ICU.
timeFrame: From the date of enrolment through to the date of ICU discharge, an average of 11 days
measure: To determine the implementation of infection prevention and control measures in routine ICU care for prevention of HAP/VAP.
timeFrame: From the date of enrolment through to the date of ICU discharge, an average of 11 days
measure: To determine microbiological etiology of HAP/VAP at the ICU (1).
timeFrame: Between days 7 and 10 after HAP/VAP onset
measure: To determine microbiological etiology of HAP/VAP at the ICU (2).
timeFrame: +/- 48 hours of HAP/VAP onset
measure: To determine microbiological etiology of HAP/VAP at the ICU (3)
timeFrame: +/- 48 hours of HAP/VAP onset
measure: To determine management of HAP/VAP at the ICU (1)
timeFrame: From the date of enrolment through to the date of ICU discharge, on average of 6 days
measure: To determine management of HAP/VAP at the ICU (2)
timeFrame: From the date of enrolment through to the date of ICU discharge, on average of 11 days
measure: To determine management of HAP/VAP at the ICU (3).
timeFrame: 90 days after HAP/VAP onset
measure: To determine outcome of HAP/VAP at the ICU (1).
timeFrame: From the date of HAP/VAP onset through to the date of ICU discharge, on average of 11 days
measure: To determine outcome of HAP/VAP at the ICU (2).
timeFrame: From the date of HAP/VAP onset through to the date of hospital discharge, on average of 12 days
measure: To determine outcome of HAP/VAP at the ICU (3).
timeFrame: From the date of enrolment through to the date of ICU discharge, on average of 11 days
measure: To determine outcome of HAP/VAP at the ICU (4).
timeFrame: From the date of enrolment through to the date of hospital discharge, on average of 12 days
Other outcomes:
Locations:
city: Tirana
country: Albania
facility: University Trauma Hospital
city: Rijeka
country: Croatia
facility: Clinical Hospital Center Rijeka
city: Slavonski Brod
country: Croatia
facility: General Hospital Dr Josip Bencevic Slavonski Brod
city: Kolín
country: Czechia
facility: Regional Hospital Kolin
city: Praha
country: Czechia
facility: General University Hospital Prague
city: Praha
country: Czechia
facility: University Hospital Kralovske Vinohrady
city: Praha
country: Czechia
facility: University Hospital Motol
city: Limoges
country: France
facility: CHU de Limoges
city: Liepāja
country: Latvia
facility: Liepaja Regional Hospital
city: Riga
country: Latvia
facility: Paul Stradins Clinical University Hospital
city: Bucharest
country: Romania
facility: Central Military Emergency University Hospital "Dr. Carol Davila "
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Novi Sad
country: Serbia
facility: Institute for Pulmonary Diseases of Vojvodina
Study officials:
affiliation: UMC Utrecht
name: Marc Bonten, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: