HOspital NEtwork STudy - Preparation for a Randomized Evaluation of Anti-Pneumonia Strategies
NCT ID: NCT05060718
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2165 participants
OBSERVATIONAL
2020-05-20
2023-01-12
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Universiteit Antwerpen
OTHER
University Hospital, Geneva
OTHER
UMC Utrecht
OTHER
Responsible Party
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MJM Bonten
Professor of molecular epidemiology of infectious diseases, head of department of medical microbiology
Principal Investigators
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Marc Bonten, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht
Locations
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University Trauma Hospital
Tirana, , Albania
Clinical Hospital Center Rijeka
Rijeka, , Croatia
General Hospital Dr Josip Bencevic Slavonski Brod
Slavonski Brod, , Croatia
Regional Hospital Kolin
Kolín, , Czechia
General University Hospital Prague
Prague, , Czechia
University Hospital Kralovske Vinohrady
Prague, , Czechia
University Hospital Motol
Prague, , Czechia
CHU de Limoges
Limoges, , France
Liepaja Regional Hospital
Liepāja, , Latvia
Paul Stradins Clinical University Hospital
Riga, , Latvia
Central Military Emergency University Hospital "Dr. Carol Davila "
Bucharest, , Romania
Elias University Emergency Hospital
Bucharest, , Romania
Clinical Center of Serbia
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
Clinical Center of Vojvodina
Novi Sad, , Serbia
Institute for Pulmonary Diseases of Vojvodina
Novi Sad, , Serbia
Countries
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Related Links
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COMBACTE (COMbatting BACterial resistance in Europe) consortium website: HONEST-PREPS is WP2-4 (Work Package) of COMBACTE-NET
Other Identifiers
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HONEST-PREPS
Identifier Type: -
Identifier Source: org_study_id