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

NCT ID: NCT04381247

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 550 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-15
• Study Completion Date: 2024-12-31

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.

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Molecular diagnostics in HAP and VAP

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: collaborator

Vestre Viken Hospital Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lars Heggelund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vestre Viken Hospital Trust

Harleen Grewal, MD, PhD

Role: STUDY_DIRECTOR

University of Bergen

Elling Ulvestad, MD, PhD

Role: STUDY_DIRECTOR

University of Bergen

Locations

Vestre Viken Health Trust

Drammen, Akershus, Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Lars Heggelund, MD, PhD

Role: CONTACT

Phone: +47 48285882

Email: lars.heggelund@vestreviken.no

Harleen Grewal, MD, PhD

Role: CONTACT

Phone: +47 99450554

Email: harleen@grewal@uib.no

Facility Contacts

Lars Heggelund, MD; PhD

Role: primary

Other Identifiers

VV HVAPNOR

Identifier Type: -

Identifier Source: org_study_id