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Comprehensive Molecular Diagnosis and Management of Hospital- and Ventilator-associated Pneumonia in Norway

Comprehensive Molecular Diagnosis and Management of Hospital- and Ventilator-associated Pneumonia in Norway

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04381247
Acronym
HVAPNOR
Enrollment
550
Registered
2020-05-08
Start date
2021-06-15
Completion date
2024-12-31
Last updated
2021-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic Resistant Infection, Hospital-acquired Pneumonia, Infection, Hospital, Infectious Disease, Pneumonia, Ventilator-Associated

Keywords

pneumonia, hospital-acquired pneumonia, ventilator-associated pneumonia, molecular diagnostics, biomarker, antibiotic stewardship

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTMolecular diagnostics in HAP and VAP

Airway samples will be analyzed both by standard and molecular based microbiological analysis.

Sponsors

Haukeland University Hospital
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Vestre Viken Hospital Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

A case definition of NV-HAP and VAP will be applied according to the 2005 American Thoracic Society and Infectious Disease Society of America´s clinical practice guidelines (unchanged in the 2016 revision). Inclusion criteria: * 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change from empirical to targeted antimicrobial treatmentSeptember 2020-August 2022Percentage based upon optimized microbiological diagnostics
Time to microbiological diagnoseSeptember 2020-August 2022Hours
Microbiological diagnoseSeptember 2020-August 2022Microbes
Prevalence of resistance mutationsSeptember 2020-August 2022Types and numbers
Time to targeted antimicrobial treatmentSeptember 2020-August 2022Hours

Countries

Norway

Contacts

Primary ContactLars Heggelund, MD, PhD
lars.heggelund@vestreviken.no+47 48285882
Backup ContactHarleen Grewal, MD, PhD
harleen@grewal@uib.no+47 99450554

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026