Impact of Molecular Testing on Improved Diagnosis, Treatment and Management of CAP

Summary

Investigators will recruit patients suspected of community-acquired pneumonia at Haukeland University Hospital, Bergen, into a pragmatic randomized controlled trial to assess if provision of ultra-rapid, high-quality accurate molecular diagnostics with direct feedback to the clinician can facilitate pathogen-directed usage of antibiotics, shorten antibiotic exposure and admission time and is safe. Additionally, transcriptional and immune marker profiling of patients will guide appropriate management through a targeted focus on the individual patient's physical capacity, nutritional status and co- morbidities. The pragmatic design of this trial together with broad inclusion criteria and a straightforward intervention would make our results generalisable to other similar centres.

Conditions

• Pneumonia

Interventions

DIAGNOSTIC_TEST

Ultra-rapid molecular point-of-care testing

Ultra-rapid molecular testing (UR-MT) comprises automated detection using the new BioFire® FilmArray® Pneumonia plus platform (Biomérieux). The total turn-around time is \<2 hrs. The UR-MT is combined with standard of care, comprising: Microbiological processing per current standard of care entails culture of respiratory tract samples according to national protocols to detect respiratory bacteria, identified using biochemical methods and/or matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF MS). Respiratory viruses are identified using real-time PCR (for metapneumovirus, rhinovirus, influenza A, influenza B, parainfluenza 1-3, RSV and SARS-CoV-2). The total turn-around time is up to 48 hrs.

Sponsors & Collaborators

• University of Bergen

  collaborator OTHER

• Drammen sykehus

  collaborator OTHER

• University of Copenhagen

  collaborator OTHER

• Rigshospitalet, Denmark

  collaborator OTHER

• UMC Utrecht

  collaborator OTHER

• University of Southampton

  collaborator OTHER

• Quadram Institute Bioscience

  collaborator OTHER

• Haukeland University Hospital

  lead OTHER

Principal Investigators

• Harleen Grewal, MD PhD · Haukeland University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-25

Primary Completion

2022-06-21

Completion

2022-06-21

Countries

• Norway

Study Locations