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

NCT04381247 | Unknown FDA Device

• 1 other identifier: VV HVAPNOR
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

HVAPNOR consists of Three work packages:

1. 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. 2.Biomarker studies in HAP and VAP.
3. 3.Studies on capacity building in HAP and VAP diagnostics.

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

Outcome Measures

Primary Outcomes (5)

• Time to microbiological diagnose

  Hours

  September 2020-August 2022

• Microbiological diagnose

  Microbes

  September 2020-August 2022

• Prevalence of resistance mutations

  Types and numbers

  September 2020-August 2022

• Change from empirical to targeted antimicrobial treatment

  Percentage based upon optimized microbiological diagnostics

  September 2020-August 2022

• Time to targeted antimicrobial treatment

  Hours

  September 2020-August 2022

Interventions

Molecular diagnostics in HAP and VAP DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients developing pneumonia during hospital stay for other cause.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vestre Viken Hospital Trust: lead
• Haukeland University Hospital: collaborator
• University of Bergen: collaborator

Study Sites (1)

Vestre Viken Health Trust

Drammen, Akershus, 3004, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Airway sampling, Whole blood, serum, plasma, faecal and urinary samples.

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Communicable Diseases; Cross Infection; Pneumonia

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lars Heggelund, MD, PhD

  Vestre Viken Hospital Trust

  PRINCIPAL INVESTIGATOR

• Harleen Grewal, MD, PhD

  University of Bergen

  STUDY DIRECTOR

• Elling Ulvestad, MD, PhD

  University of Bergen

  STUDY DIRECTOR

Central Study Contacts

Lars Heggelund, MD, PhD

CONTACT

+47 48285882; lars.heggelund@vestreviken.no

Harleen Grewal, MD, PhD

CONTACT

+47 99450554; harleen@grewal@uib.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 8, 2020
• Study Start: June 15, 2021
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2024
• Last Updated: December 6, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: September 2020-December 2024.
• Access Criteria: PI must be contacted

Locations

NO (1)