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

Infectious Disease Clinical Trial

— HVAPNOR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04381247
• Other study ID #: VV HVAPNOR
• Status: Recruiting
• Start date: June 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: December 2021
• Source: Vestre Viken Hospital Trust
• Contact: Lars Heggelund, MD, PhD
• Phone: +47 48285882
• Email: lars.heggelund[@]vestreviken.no
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. Studies on capacity building in HAP and VAP diagnostics.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 550
• Est. completion date: December 2024
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antibiotic Resistant Infection
• Communicable Diseases
• Cross Infection
• Healthcare-Associated Pneumonia
• Hospital-acquired Pneumonia
• Infection, Hospital
• Infections
• Infectious Disease
• Pneumonia
• Pneumonia, Ventilator-Associated

Intervention

Diagnostic Test:
• Molecular diagnostics in HAP and VAP
Airway samples will be analyzed both by standard and molecular based microbiological analysis.

Locations

Country	Name	City	State
Norway	Vestre Viken Health Trust	Drammen	Viken

Sponsors (3)

Lead Sponsor	Collaborator
Vestre Viken Hospital Trust	Haukeland University Hospital, University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to microbiological diagnose	Hours	September 2020-August 2022
Primary	Microbiological diagnose	Microbes	September 2020-August 2022
Primary	Prevalence of resistance mutations	Types and numbers	September 2020-August 2022
Primary	Change from empirical to targeted antimicrobial treatment	Percentage based upon optimized microbiological diagnostics	September 2020-August 2022
Primary	Time to targeted antimicrobial treatment	Hours	September 2020-August 2022