Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway: a pragmatic randomised controlled trial (CAPNOR)
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Background: Community-acquired pneumonia (CAP) causes a large burden of disease. Due to difficulties in obtaining representative respiratory samples and insensitive standard microbiological methods, the microbiological aetiology of CAP is difficult to ascertain. With a few exceptions, standard-of-care diagnostics are too slow to influence initial decisions on antimicrobial therapy. The management of CAP is therefore largely based on empirical treatment guidelines. Empiric antimicrobial therapy is often initiated in the primary care setting, affecting diagnostic tests based on conventional bacterial culture in hospitalized patients. Implementing rapid molecular testing may improve both the proportion of positive tests and the time it takes to obtain test results. Both measures are important for initiation of pathogen-targeted antibiotics, involving rapid de-escalation or escalation of treatment, which may improve antimicrobial stewardship and potentially patient outcome. Methods: Patients presenting to the emergency department of Haukeland University Hospital (HUH) in Bergen, Norway, will be screened for inclusion into a pragmatic randomised controlled trial (RCT). Eligible patients with a suspicion of CAP will be included and randomised to receive either standard-of-care methods (standard microbiological testing) or standard-of-care methods in addition to testing by the rapid and comprehensive real-time multiplex PCR panel, the BioFire® FilmArray® Pneumonia Panel plus (FAP plus) (bioMérieux S.A., Marcy-l’Etoile, France). The results of the FAP plus will be communicated directly to the treating staff within ~2 h of sampling. Discussion: We will examine if rapid use of FAP plus panel in hospitalized patients with suspected CAP can improve both the time to and the proportion of patients receiving pathogen-directed treatment, thereby shortening the exposure to unnecessary antibiotics and the length of hospital admission, compared to the standard-of-care arm. The pragmatic design together with broad inclusion criteria and a straightforward intervention could make our results generalizable to other similar centres. Trial registration: ClinicalTrials.govNCT04660084. Registered on December 9, 2020
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 622 |
| Tidsskrift | Trials |
| Vol/bind | 23 |
| ISSN | 1745-6215 |
| DOI | |
| Status | Udgivet - 2022 |
Bibliografisk note
Funding Information:
TWC has received speaker fees, honoraria, travel reimbursement and equipment and consumables at a discount or free of charge for the purposes independent of research, outside of this submitted study, from BioFire diagnostics, BioMérieux and QIAGEN. TWC has received consultancy fees from Cepheid, Synairgen research, Randox laboratories and Cidara therapeutics. He has received honoraria for participation in advisory boards and consultancy fees from Cepheid, Roche, Janssen and Shionogi. He is a member of independent data monitoring committees for trials sponsored by Roche. He has acted as the UK chief investigator for studies sponsored by Janssen. C. H. van Werkhoven has received non-financial and financial research support from BioMérieux outside this submitted study. The other authors have nothing to disclose.
Funding Information:
Open access funding provided by University of Bergen. This work was supported financially by the funding from the Research Council of Norway (NORCAP; 288718), who is the principal funder of the trial. Co-funding was obtained from the Trond Mohn Foundation (COVID-19 CAPNOR; TMS2020TMT07 and RESPNOR; BFS2019TMT06), the University of Bergen and Haukeland University Hospital. The funders had no role in the study design and will have no role in the collection, management, analysis and interpretation of data nor in the decision to submit the report for publication.
Funding Information:
We gratefully acknowledge the staff at the Emergency Care Clinic, the staff at the Department of Microbiology and the CAPNOR study group§.§CAPNOR study group (alphabetical listing): R. Bjørneklett1,2, T.W. Clark8, M. Ebbesen4, D. Faurholt-Jepsen3,7, H.M.S. Grewal3,4, L. Heggelund3,5, S.T. Knoop1,4, Ø. Kommedal3,4, D. Markussen1, P. Ravn10, C. Ritz3,9, S. Serigstad1,2, E. Ulvestad3,4, C.H. Van Werkhoven61Emergency Care Clinic, Haukeland University Hospital, Bergen, Norway2Department of Clinical Medicine, Faculty of Medicine, University of Bergen, Bergen, Norway3Department of Clinical Science, Bergen Integrated Diagnostic Stewardship cluster, Faculty of Medicine, University of Bergen, Bergen, Norway4Department of Microbiology, Haukeland University Hospital, Bergen, Norway5Department of Internal Medicine, Vestre Viken Hospital Trust, Drammen, Norway.6Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.7Department of Infectious Diseases, Rigshospitalet, Denmark.8School of Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK9National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark10Department of Internal Medicine, Section for Infectious Diseases, Herlev and Gentofte Hospital, Hellerup, Denmark.
Publisher Copyright:
© 2022, The Author(s).
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