TY - JOUR

T1 - Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway

T2 - a pragmatic randomised controlled trial (CAPNOR)

AU - Serigstad, S.

AU - Ritz, Christian

AU - Faurholt-Jepsen, Daniel

AU - Markussen, D.

AU - Ebbesen, Marit H.

AU - Kommedal, null

AU - Bjørneklett, R.

AU - Heggelund, L.

AU - Clark, Tristan W.

AU - Van Werkhoven, C. H.

AU - Knoop, S. T.

AU - Ulvestad, E.

AU - Grewal, Harleen M.S.

AU - Bjørneklett, R.

AU - Clark, T. W.

AU - Ebbesen, M.

AU - Grewal, H. M.S.

AU - Heggelund, L.

AU - Knoop, S. T.

AU - Kommedal, null

AU - Markussen, D.

AU - Ravn, P.

AU - Ritz, C.

AU - Serigstad, S.

AU - Ulvestad, E.

AU - Van Werkhoven, C. H.

AU - the CAPNOR study group

N1 - Publisher Copyright: © 2022, The Author(s).

PY - 2022

Y1 - 2022

N2 - 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

AB - 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

KW - Antimicrobial treatment

KW - Community-acquired pneumonia

KW - FilmArray Pneumonia Panel

KW - Induced sputum

KW - Microbiological testing

KW - Molecular testing

KW - Rapid diagnostics

KW - Respiratory tract infections

KW - Syndromic PCR panel

U2 - 10.1186/s13063-022-06467-7

DO - 10.1186/s13063-022-06467-7

M3 - Journal article

C2 - 35915452

AN - SCOPUS:85135363640

VL - 23

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 622

ER -