Hospital-acquired PneumoniaHONEST-PREPSNCT05060718
HOspital NEtwork STudy - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies
An observational study of Hospital-acquired Pneumonia and Ventilator Associated Pneumonia, run by UMC Utrecht at 16 sites in 7 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-acquired Pneumonia, Ventilator Associated Pneumonia
- How many people
- 2,165 participants
- Where
- 16 sitesin 7 countries
- Study dates
- 20 May 2020to 12 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to an ICU at risk of bacterial HAP/VAP are eligible to participate in the study.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 7 countries.
16 sites in 7 countries
Czechia4 sites
Regional Hospital Kolin
Kolín
General University Hospital Prague
Prague
University Hospital Kralovske Vinohrady
Prague
University Hospital Motol
Prague
Serbia4 sites
Clinical Center of Serbia
Belgrade
Clinical Center Kragujevac
Kragujevac
Clinical Center of Vojvodina
Novi Sad
Institute for Pulmonary Diseases of Vojvodina
Novi Sad
Croatia2 sites
Clinical Hospital Center Rijeka
Rijeka
General Hospital Dr Josip Bencevic Slavonski Brod
Slavonski Brod
Latvia2 sites
Liepaja Regional Hospital
Liepāja
Paul Stradins Clinical University Hospital
Riga
Romania2 sites
Central Military Emergency University Hospital "Dr. Carol Davila "
Bucharest
Elias University Emergency Hospital
Bucharest
About this study
Official title: HONEST-PREPS: Hospital Network Study - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies
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.
- Medical subject headings
- Healthcare-Associated Pneumonia, Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through study completion, an average of 2 years
Secondary outcomes (12)
To determine the incidence of HAP/VAP at the ICU.
-Incidence of HAP and VAP per 1,000 patient-days
Measured: 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.
-Implementation of ICU-level HAP/VAP infection prevention measures
Measured: 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).
-Microbiological cure between 7 and 10 days after HAP/VAP onset (%). (Proportion of patients with positive HAP/VAP diagnosis with the resolution of the symptoms between day 7-10 after the onset)
Measured: Between days 7 and 10 after HAP/VAP onset
To determine microbiological etiology of HAP/VAP at the ICU (2).
-Distribution of bacterial pathogens (%). (Proportion of identified bacterial pathogens associated with HAP/VAP episode).
Measured: +/- 48 hours of HAP/VAP onset
To determine microbiological etiology of HAP/VAP at the ICU (3)
-Resistance profiles of bacterial pathogens (% resistant) (proportion of resistant bacterial pathogen associated with HAP/VAP episode).
Measured: +/- 48 hours of HAP/VAP onset
To determine management of HAP/VAP at the ICU (1)
-IMV (Invasive Mechanical Ventilation)-free-days up to 28 days after VAP onset (days).
Measured: From the date of enrolment through to the date of ICU discharge, on average of 6 days
To determine management of HAP/VAP at the ICU (2)
-Antibiotic consumption before and after HAP/VAP (type of antibiotic administered per patient).
Measured: From the date of enrolment through to the date of ICU discharge, on average of 11 days
To determine management of HAP/VAP at the ICU (3).
-Survival up to 90 days post HAP/VAP onset rate (%) (Proportion of patient's confirmed alive vs. dead in %)
Measured: 90 days after HAP/VAP onset
To determine outcome of HAP/VAP at the ICU (1).
-ICU survival rate (%). (Proportion of patients discharged from ICU alive vs. patients with in-ICU death)
Measured: From the date of HAP/VAP onset through to the date of ICU discharge, on average of 11 days
To determine outcome of HAP/VAP at the ICU (2).
-Hospital survival rate (%). (Proportion of patients discharged from hospital alive vs. patients with in-hospital death)
Measured: From the date of HAP/VAP onset through to the date of hospital discharge, on average of 12 days
To determine outcome of HAP/VAP at the ICU (3).
-Length of ICU stay before and after HAP/VAP (number of days spent in ICU before and after HAP/VAP onset)
Measured: From the date of enrolment through to the date of ICU discharge, on average of 11 days
To determine outcome of HAP/VAP at the ICU (4).
-Length of hospital stay before and after HAP/VAP (number of days spent in hospital before and after HAP/VAP onset).
Measured: From the date of enrolment through to the date of hospital discharge, on average of 12 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start20 May 2020
- Primary completion31 May 2022
- Study completion12 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,165 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, University Hospital, Geneva
- Responsible party
- Principal investigator, MJM Bonten, UMC Utrecht
- Investigators
- Marc Bonten, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060718
- Sponsor's protocol ID
- HONEST-PREPS
- Acronym
- HONEST-PREPS
- Status last verified
- Dec 2022
- First submitted
- 20 Jul 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jackson H, Sauser J, van Werkhoven CH, Harbarth S, de Kraker MEA. Benefits of group sequential design and sample size re-estimation for randomised controlled trials evaluating the prevention of ventilator-associated pneumonia: a simulation study informed by real world data. BMC Med Res Methodol. 2025 Nov 12;25(1):254. doi: 10.1186/s12874-025-02681-4.
PubMed 41225316
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HONEST-PREPS: Hospital Network Study - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies
- ClinicalTrials.gov ID
- NCT05060718
- Acronym / sponsor ID
- HONEST-PREPS / HONEST-PREPS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,165 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, University Hospital, Geneva
- Study start
- 20 May 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 12 Jan 2023 (actual)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to an ICU at risk of bacterial HAP/VAP are eligible to participate in the study.
Key inclusion criteria (4 listed)
- Age >= 18 years
- At risk of acquiring bacterial HAP or VAP during ICU stay, defined as meeting all of the following criteria:
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by measuring the timeliness of enrolling eligible patients.
Time frame: Through study completion, an average of 2 years
Assess the proportion of screened, eligible patients at risk of developing HAP or VAP by being enrolled within 48 hours of ICU admission.
To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by capturing bacterial HAP/VAP episodes.
Time frame: Through study completion, an average of 2 years
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.
12 secondary outcomes
To determine the incidence of HAP/VAP at the ICU.
Time frame: 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.
Time frame: 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).
Time frame: Between days 7 and 10 after HAP/VAP onset
To determine microbiological etiology of HAP/VAP at the ICU (2).
Time frame: +/- 48 hours of HAP/VAP onset
To determine microbiological etiology of HAP/VAP at the ICU (3)
Time frame: +/- 48 hours of HAP/VAP onset
To determine management of HAP/VAP at the ICU (1)
Time frame: From the date of enrolment through to the date of ICU discharge, on average of 6 days
To determine management of HAP/VAP at the ICU (2)
Time frame: From the date of enrolment through to the date of ICU discharge, on average of 11 days
To determine management of HAP/VAP at the ICU (3).
Time frame: 90 days after HAP/VAP onset
To determine outcome of HAP/VAP at the ICU (1).
Time frame: From the date of HAP/VAP onset through to the date of ICU discharge, on average of 11 days
To determine outcome of HAP/VAP at the ICU (2).
Time frame: From the date of HAP/VAP onset through to the date of hospital discharge, on average of 12 days
To determine outcome of HAP/VAP at the ICU (3).
Time frame: From the date of enrolment through to the date of ICU discharge, on average of 11 days
To determine outcome of HAP/VAP at the ICU (4).
Time frame: From the date of enrolment through to the date of hospital discharge, on average of 12 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 41225316Jackson H, Sauser J, van Werkhoven CH, Harbarth S, de Kraker MEA. Benefits of group sequential design and sample size re-estimation for randomised controlled trials evaluating the prevention of ventilator-associated pneumonia: a simulation study informed by real world data. BMC Med Res Methodol. 2025 Nov 12;25(1):254. doi: 10.1186/s12874-025-02681-4.
- COMBACTE (COMbatting BACterial resistance in Europe) consortium website: HONEST-PREPS is WP2-4 (Work Package) of COMBACTE-NETLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Bonten, MD, PhD principal investigator
UMC Utrecht
16 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospital-acquired Pneumonia and Ventilator Associated Pneumonia, run by UMC Utrecht at 16 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Czechia, Serbia, Croatia, Latvia, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the quality and efficiency of a research platform for HAP/VAP in ICUs by measuring the timeliness of enrolling eligible patients. (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05060718, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.