Pneumonia, Ventilator-AssociatedHVAPNORNCT04381247
Comprehensive Molecular Diagnosis and Management of Hospital- and Ventilator-associated Pneumonia in Norway
An observational study of Pneumonia, Ventilator-Associated and Hospital-acquired Pneumonia, run by Vestre Viken Hospital Trust at 1 site in Norway.
Trial summary
HVAPNOR consists of Three work packages: 1. Prospective observational study of Hospital (HAP) - and ventilator-Associated pneumonia (VAP) at 5 hospitals in Norway. Establish optimized routines for microbiological sampling, diagnostics and antibiotic stewardship.. 2. Biomarker studies in HAP and VAP. 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Ventilator-Associated, Hospital-acquired Pneumonia, Infectious Disease
- What is being tested?
- Molecular diagnostics in HAP and VAP
- How many people
- 550 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jun 2021to Dec 2024
- How long will I take part?
- 2 Years
- 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 developing pneumonia during hospital stay for other cause.
Who may be able to join
- Age ≥18 years
- Meets case definition criteria (patient admitted to hospital or endotracheal intubation ≥ 48 hours, a new lung infiltrate + ≥2 of the following: temperature >38˚C, leukocytes <3.5 or >11.0, purulent secretions)
- Eligible for lower airways sampling
- Written informed consent
Who cannot join
- Pulmonary embolism, segmental or larger
- Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s)
- Glasgow Coma Scale score 3
- Patients not eligible for lower airways sampling
- Palliative situation with life expectancy < 1 week
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Vestre Viken Health Trust
Drammen, Akershus, 3004
Lars Heggelund, MD; PhD, +47 482 85 882, lars.heggelund@vestreviken.no
About this study
HVAPNOR consists of Three work packages:
- Prospective observational study of Hospital (HAP) - and ventilator-Associated pneumonia (VAP) at 5 hospitals in Norway. Establish optimized routines for microbiological sampling, diagnostics and antibiotic stewardship..
- Biomarker studies in HAP and VAP.
- Studies on capacity building in HAP and VAP diagnostics.
Read the detailed description
Lower respiratory tract infections include hospital-acquired pneumonia (HAP) and ventilator- associated pneumonia (VAP) with a very high mortality in critically ill patients. Diagnosis is difficult with an inherent uncertainty and complicated by comorbidity, lack of routines for high-quality airway sampling and low sensitivity of routine microbiological tests. There is limited data on the aetiology and burden from HAP and VAP, and to the investigators knowledge, no previous prospective HAP and VAP studies has been performed in Norway. In the absence of rapid and accurate microbiological diagnosis, seriously ill HAP and VAP patients are often provided broad-spectrum antibiotics that have to be active on putative multi-drug resistant (MDR) bacteria, as failure to initiate prompt adequate therapy is associated with increased mortality. Overuse of broad-spectrum antibiotics promotes the selection and dissemination of MDR bacteria.
HVAPNOR brings together a multidisciplinary research team from Norwegian (Haukeland University Hospital (HUS), University of Bergen (UoB), Vestre Viken Hospital Trust (VVHF), and international institutions (Denmark, Netherlands and United Kingdom), with a strong record in respiratory disease research.
The overall aims of the HVAPNOR study are to improve diagnostic methods, antibiotic stewardship, treatment and management of HAP and VAP. The investigators will in a Norwegian context, map the incidence and the aetiology of HAP/VAP infections. During a two-year period, adult HAP and VAP patients admitted at HUS and VVHF, will be identified and voluntarily included in a prospective descriptive study. The project will strengthen the routines for adequate airway sampling and assess if provision of ultra-rapid, high-quality accurate molecular diagnostics will provide a more comprehensive microbiological etiological diagnose than routine analysis. A direct feedback to the clinician can facilitate pathogen-directed usage of antibiotics. We will evaluate the potential of molecular diagnostic platforms for the detection of pathogens and antimicrobial markers in HAP and VAP. Furthermore, the investigators will identify barriers that inhibit the acceptance of rapid molecular tests; and contribute to the optimisation of treatment protocols for HAP and VAP.
Finally, the study will also evaluate and identify new and clinically relevant diagnostic and prognostic biomarkers, including immune biomarkers and transcriptional profiling, in HAP and VAP.
The HVAPNOR study is in line with the objectives of the funding agencies, addresses clinical research activities to help to ensure that patients receive high-quality and reliable diagnostics and optimized treatment.
- Conditions
- Pneumonia, Ventilator-Associated, Hospital-acquired Pneumonia, Infectious Disease, Infection, Hospital, Antibiotic Resistant Infection
- Being tested
- Molecular diagnostics in HAP and VAP
- Keywords
- pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, molecular diagnostics, biomarker, antibiotic stewardship
- Medical subject headings
- Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Communicable Diseases, Cross Infection, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecular diagnostics in HAP and VAPDiagnostic test
Airway samples will be analyzed both by standard and molecular based microbiological analysis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to microbiological diagnose
Hours
Measured: September 2020-August 2022
Microbiological diagnose
Microbes
Measured: September 2020-August 2022
Prevalence of resistance mutations
Types and numbers
Measured: September 2020-August 2022
Change from empirical to targeted antimicrobial treatment
Percentage based upon optimized microbiological diagnostics
Measured: September 2020-August 2022
Time to targeted antimicrobial treatment
Hours
Measured: September 2020-August 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start15 Jun 2021
- Primary completionAug 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, Ventilator-AssociatedStudies of the same condition, open and under way.
- 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
- 550 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Vestre Viken Hospital Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital, University of Bergen
- Responsible party
- Sponsor
- Investigators
- Lars Heggelund, MD, PhD, Principal investigator, Vestre Viken Hospital TrustHarleen Grewal, MD, PhD, Study director, University of BergenElling Ulvestad, MD, PhD, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381247
- Sponsor's protocol ID
- VV HVAPNOR
- Acronym
- HVAPNOR
- Status last verified
- Dec 2021
- First submitted
- 5 May 2020
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Study protocol, SAP and ICF will be made avialbe after the study has been initiated. CSR will be made avialbel after publication.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Molecular Diagnosis and Management of Hospital- and Ventilator-associated Pneumonia in Norway
- ClinicalTrials.gov ID
- NCT04381247
- Acronym / sponsor ID
- HVAPNOR / VV HVAPNOR
- Conditions
- Pneumonia, Ventilator-Associated, Hospital-acquired Pneumonia, Infectious Disease, Infection, Hospital, Antibiotic Resistant Infection
- Keywords
- pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, molecular diagnostics, biomarker, antibiotic stewardship
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Vestre Viken Hospital TrustUniversity, hospital or other
- Collaborators
- Haukeland University Hospital, University of Bergen
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 May 2020 (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.
HVAPNOR consists of Three work packages:
- Prospective observational study of Hospital (HAP) - and ventilator-Associated pneumonia (VAP) at 5 hospitals in Norway. Establish optimized routines for microbiological sampling, diagnostics and antibiotic stewardship..
- Biomarker studies in HAP and VAP.
- Studies on capacity building in HAP and VAP diagnostics.
Detailed description
Lower respiratory tract infections include hospital-acquired pneumonia (HAP) and ventilator- associated pneumonia (VAP) with a very high mortality in critically ill patients. Diagnosis is difficult with an inherent uncertainty and complicated by comorbidity, lack of routines for high-quality airway sampling and low sensitivity of routine microbiological tests. There is limited data on the aetiology and burden from HAP and VAP, and to the investigators knowledge, no previous prospective HAP and VAP studies has been performed in Norway. In the absence of rapid and accurate microbiological diagnosis, seriously ill HAP and VAP patients are often provided broad-spectrum antibiotics that have to be active on putative multi-drug resistant (MDR) bacteria, as failure to initiate prompt adequate therapy is associated with increased mortality. Overuse of broad-spectrum antibiotics promotes the selection and dissemination of MDR bacteria.
HVAPNOR brings together a multidisciplinary research team from Norwegian (Haukeland University Hospital (HUS), University of Bergen (UoB), Vestre Viken Hospital Trust (VVHF), and international institutions (Denmark, Netherlands and United Kingdom), with a strong record in respiratory disease research.
The overall aims of the HVAPNOR study are to improve diagnostic methods, antibiotic stewardship, treatment and management of HAP and VAP. The investigators will in a Norwegian context, map the incidence and the aetiology of HAP/VAP infections. During a two-year period, adult HAP and VAP patients admitted at HUS and VVHF, will be identified and voluntarily included in a prospective descriptive study. The project will strengthen the routines for adequate airway sampling and assess if provision of ultra-rapid, high-quality accurate molecular diagnostics will provide a more comprehensive microbiological etiological diagnose than routine analysis. A direct feedback to the clinician can facilitate pathogen-directed usage of antibiotics. We will evaluate the potential of molecular diagnostic platforms for the detection of pathogens and antimicrobial markers in HAP and VAP. Furthermore, the investigators will identify barriers that inhibit the acceptance of rapid molecular tests; and contribute to the optimisation of treatment protocols for HAP and VAP.
Finally, the study will also evaluate and identify new and clinically relevant diagnostic and prognostic biomarkers, including immune biomarkers and transcriptional profiling, in HAP and VAP.
The HVAPNOR study is in line with the objectives of the funding agencies, addresses clinical research activities to help to ensure that patients receive high-quality and reliable diagnostics and optimized treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients developing pneumonia during hospital stay for other cause.
Key inclusion criteria (4 listed)
- Age ≥18 years
- Meets case definition criteria (patient admitted to hospital or endotracheal intubation ≥ 48 hours, a new lung infiltrate + ≥2 of the following: temperature >38˚C, leukocytes <3.5 or >11.0, purulent secretions)
- Eligible for lower airways sampling
- Written informed consent
Key exclusion criteria (5 listed)
- Pulmonary embolism, segmental or larger
- Refractory septic shock (meeting the Sepsis-3 definition of septic shock, and requiring vasopressors ≥ 0.5 mcg/kg/min noradrenaline or equivalent dose of other vasopressor(s)
- Glasgow Coma Scale score 3
- Patients not eligible for lower airways sampling
- Palliative situation with life expectancy < 1 week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecular diagnostics in HAP and VAPAirway samples will be analyzed both by standard and molecular based microbiological analysis. | Diagnostic test | – |
Primary outcome
Time to microbiological diagnose
Time frame: September 2020-August 2022
Hours
Microbiological diagnose
Time frame: September 2020-August 2022
Microbes
Prevalence of resistance mutations
Time frame: September 2020-August 2022
Types and numbers
Change from empirical to targeted antimicrobial treatment
Time frame: September 2020-August 2022
Percentage based upon optimized microbiological diagnostics
Time to targeted antimicrobial treatment
Time frame: September 2020-August 2022
Hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: Yes. Study protocol, SAP and ICF will be made avialbe after the study has been initiated. CSR will be made avialbel after publication.
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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.
Lars Heggelund, MD, PhD principal investigator
Vestre Viken Hospital Trust
Harleen Grewal, MD, PhD study director
University of Bergen
Elling Ulvestad, MD, PhD study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Ventilator-Associated and Hospital-acquired Pneumonia, run by Vestre Viken Hospital Trust at 1 site in Norway.
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 5 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: status not confirmed, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Heggelund, MD, PhD (+47 48285882, lars.heggelund@vestreviken.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to microbiological diagnose (time frame: September 2020-August 2022). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2021.