Impact of rapid molecular testing on diagnosis, treatment and management of community-acquired pneumonia in Norway: a pragmatic randomised controlled trial (CAPNOR)

Abstract

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

Evaluating the Impact of Diagnostic Stewardship in Community-Acquired Pneumonia with Syndromic Molecular Testing: A Randomized Clinical Trial

“…Patients were ineligible if they had cystic fibrosis, severe bronchiectasis, hospitalization within the last 14 days prior to admission, a palliative approach was being taken (defined as life expectancy below two weeks), or if they were not willing to provide an LRT sample. 13 Written informed consent was obtained from all patients or from their legal guardian/close relatives.…”

Antibiotic Consumption in a Cohort of Hospitalized Adults with Viral Respiratory Tract Infection

“…In many situations, antibiotic initiation happens early in the course of infection based solely on a clinical evaluation, which in most cases cannot distinguish between bacterial and viral RTIs [ 13 , 14 , 37 ]. Clinical observations such as respiratory rate, heart rate and oxygen saturation are potential factors that may help the clinician in evaluating the severity of the infection, but not the etiology.…”

Diagnostic Stewardship in Community-Acquired Pneumonia With Syndromic Molecular Testing

“…Patients were eligible for inclusion if they were 18 years or older; presented to the ED with suspected CAP; and met at least 2 of the following criteria: new or worsening cough, new or worsening expectoration, new or worsening dyspnoea, hemoptysis, pleuritic chest pain, radiological evidence of pneumonia, abnormalities on chest auscultation and/or percussion, or fever (≥38.0 °C). Patients were ineligible if they had cystic fibrosis, had severe bronchiectasis, were hospitalized within the past 14 days prior to admission, were under a palliative approach (ie, life expectancy of <2 weeks), or were not willing to provide an LRT sample …”

“…This pragmatic, parallel-arm, single-blinded, single-center, randomized clinical superiority trial was conducted in the ED of Haukeland University Hospital, a large tertiary care institution in Bergen, Norway, that serves as a local hospital for approximately 470 000 residents and a referral hospital for 1 million people. The Regional Committee for Medical and Health Research Ethics in Norway approved the study protocol 13 ( Supplement 1 ). Written informed consent was obtained from all patients or their legal guardian or close relatives.…”