Community-acquired Pneumonia
Conditions
Keywords
Pneumonia, low-dose CT, low-dose computed tomography, point of care testing, multiplex PCR, lower respiratory tract infection, antibiotic stewardship
Brief summary
Rationale: Uncertainty in the clinical and etiological diagnosis of community-acquired pneumonia (CAP) often leads to incorrect treatment and unnecessary use of broad-spectrum antibiotics. Establishing the clinical diagnosis of CAP is hampered by the suboptimal sensitivity of chest radiograph to detect pulmonary infiltrates (\ 70%). Establishing the etiological diagnosis is also hampered, mainly because of the inevitable diagnostic delays and low sensitivity of routine microbiological tests. There are currently no recommendations for low-dose chest computed tomography (low-dose CT) or viral and bacterial point-of-care multiplex polymerase chain reaction (PoC-PCR) in the diagnostic work-up of CAP patients, because the data supporting such an approach are lacking. Objective: The aim of this study is to determine the added value of low-dose CT and PoC-PCR in the diagnostic workup of patients with CAP hospitalised to non-intensive care unit (ICU) wards in minimizing selective antibiotic pressure while maintaining patient safety. Study design: Cluster-randomised controlled trial with historical control period. Study population: Adult patients (\>=18 years old) with a clinical diagnosis of CAP requiring hospitalisation to a non-ICU ward. Intervention: Intervention arm 1: availability of PoC-PCR during the ER visit; intervention arm 2: performing low-dose CT from the ER or at least within 24 hours; control arm: standard care. Main study parameters/endpoints: The primary effectiveness outcome is days of therapy of broad-spectrum antibiotics. The primary safety outcome, on which the sample size is calculated, is 90-day all-cause mortality. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: There are no risks associated with performing the PoC-PCR and the radiation of the low-dose CT is of negligible risk. Nasopharyngeal swab collection causes a temporary unpleasant sensation. The low-dose CT can reveal unexpected findings which may require additional diagnostic procedures, for which the treating physician will use state-of-the-art guidelines. Treatment recommendations to de-escalate or stop antibiotic treatment may be beneficial for the individual patient by minimising exposure to antibiotics and improve targeted use of antibiotics. Final decisions are always made by the treating physician taking into account all clinical information.
Interventions
DIAGNOSTIC_TESTlow-dose CT
see arm/group description
DIAGNOSTIC_TESTPoC-PCR
see arm/group description
Sponsors
BioMérieux
MJM Bonten
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Parallel cluster-randomised trial with historical control period
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* aged 18 years or above; * working diagnosis of CAP at the emergency department with the presence of at least two clinical criteria or one clinical criterion and radiological evidence of CAP, with no other explanation for the signs and symptoms; * requiring hospitalisation to a non-ICU ward via the ER.
Exclusion criteria
* Hospitalisation for two or more days in the last 14 days; * Residence in a long-term care facility in the last 14 days; * History of cystic fibrosis; * Severe immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days of therapy of broad-spectrum antibiotics | throughout hospitalization, an average of 7 days | Days of treatment with broad-spectrum antibiotics during index admission. This will include antibiotic prescriptions provided at discharge. |
| All-cause mortality | 90 days | All-cause mortality within 90 days of admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| length of hospital stay | throughout hospitalization, an average of 7 days | — |
| adverse outcomes | 90 days | Composite endpoint comprising ICU admission, in-hospital mortality, and readmission |
| time to results | throughout hospitalization, an average of 7 days | Time from admission to availability of the low-dose CT / PoC-PCR results. |
| days of therapy with any antibiotic | throughout hospitalization, an average of 7 days | Number of days of treatment with any antibiotics during index admission, including antibiotic prescriptions provided at discharge. |
| change in antibiotic consumption | throughout hospitalization, an average of 7 days | Whether changes were made in the antibiotic class during treatment |
| time to change in antibiotic consumption | throughout hospitalization, an average of 7 days | When changes were made in the antibiotic class during treatment |
| time to treatment recommendations | throughout hospitalization, an average of 7 days | Time from admission to provision of a treatment recommendation following the low-dose CT / PoC-PCR results. |
| all-cause mortality | 30 days | — |
Countries
Netherlands
Outcome results
None listed