Back to search

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Impact of Molecular Point-of-Care Testing on Improved Diagnosis, Treatment and Management of CAP in NORWAY: a pragmatic RCT

Alternative title: Betydningen av pasientnær diagnostikk for behandling av pasienter med samfunnservervet lungebetennelse: En pragmatisk RCT

Awarded: NOK 14.9 mill.

Pneumonia is an infection of the lungs that can be acquired in the community or a hospital. Community-acquired pneumonia (CAP) causes a considerable disease burden, especially in the elderly. CAP is a serious infection, and antibiotics are given at diagnosis. The treating doctor does not initially know what microbe is responsible and gives the patient a broad-spectrum antibiotic. The treatment is then tailored to the results from the microbiology Lab. when available (which can take up to 48 hrs.). Uncertainty in diagnosis often leads to initial incorrect treatment and unnecessary use of broad-spectrum antibiotics. An intervention that can increase effective antibiotic prescribing would have a positive impact on antimicrobial resistance, hospital infections, and patient outcomes. NORCAP brings together research groups with a strong record in respiratory disease research, with the goal of contributing to improved treatment, optimized management, and rehabilitation of CAP patients in Norway. Investigators have recruited patients suspected of community-acquired pneumonia (CAP) at Haukeland University Hospital, Bergen, into a pragmatic randomized controlled trial (RCT) to assess if the 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. The pragmatic design of this trial, together with broad inclusion criteria and a straightforward intervention, makes our results generalizable to other similar centers. Additionally, this well-characterized CAP cohort of significant size will provide information on CAP etiology in Norway, and patient risk profiles (e.g., as predictors of disease outcome) will be obtained. Finally, transcriptional and immune marker profiling will identify biomarkers of CAP etiology and disease evolution. During the summer of 2023, we successfully concluded both the RCT and the subsequent prospective CAP cohort study, encompassing a total of 645 enrolled patients. Interim analyses revealed noteworthy distinctions in primary outcomes, prompting the decision to terminate the RCT prematurely. Our substantial CAP cohort is the foundation for ongoing research to fulfil the objectives outlined in the NORCAP project, including investigating aetiology, patient risk stratification, and biomarker-related goals.

Community acquired pneumonia (CAP) causes a considerable burden of disease, which in developed countries, is greatest in the elderly. CAP is associated with excess acute and long-term mortality. Diagnosis is difficult and complicated by comorbidity and low sensitivity of routine microbiological tests. Uncertainty in diagnosis often leads to incorrect treatment and unnecessary use of broad-spectrum antibiotics. Empirical antibiotics are prescribed to hospitalised patients with acute respiratory illness, including patients where viruses are implicated. Interventions to reduce excessive and increase effective antibiotic prescribing may have a positive impact on antimicrobial resistance, hospital infections, and clinical outcomes. We will recruit CAP patients at Haukeland hospital, Bergen, into a pragmatic randomised controlled trial to assess if provision of ultra-rapid, accurate molecular diagnostics (Point-of-Care Testing) 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 patients 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 similar centres. NORCAP brings together research groups with a strong record in respiratory disease research, with the shared goal of contributing to improved treatment, optimised management and rehabilitation of CAP patients in Norway. NORCAP will contribute to a) impact on diagnostic thinking b) impact on therapeutic actions c) impact on patient outcomes d) impact on societal outcomes.

Publications from Cristin

No publications found

No publications found

No publications found

No publications found

Funding scheme:

BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering