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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03360851
Other study ID # NL61857.041.17
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date November 27, 2017
Est. completion date March 1, 2021

Study information

Verified date May 2021
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3555
Est. completion date March 1, 2021
Est. primary completion date June 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
low-dose CT
see arm/group description
PoC-PCR
see arm/group description

Locations

Country Name City State
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Amphia Ziekenhuis Breda
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands Ter Gooi Ziekenhuis Hilversum
Netherlands University Medical Center Utrecht
Netherlands Maxima MC Veldhoven
Netherlands Langeland Ziekenhuis Zoetermeer

Sponsors (2)

Lead Sponsor Collaborator
MJM Bonten BioMérieux

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Days of therapy of broad-spectrum antibiotics Days of treatment with broad-spectrum antibiotics during index admission. This will include antibiotic prescriptions provided at discharge. throughout hospitalization, an average of 7 days
Primary All-cause mortality All-cause mortality within 90 days of admission. 90 days
Secondary days of therapy with any antibiotic Number of days of treatment with any antibiotics during index admission, including antibiotic prescriptions provided at discharge. throughout hospitalization, an average of 7 days
Secondary all-cause mortality 30 days
Secondary length of hospital stay throughout hospitalization, an average of 7 days
Secondary adverse outcomes Composite endpoint comprising ICU admission, in-hospital mortality, and readmission 90 days
Secondary time to results Time from admission to availability of the low-dose CT / PoC-PCR results. throughout hospitalization, an average of 7 days
Secondary time to treatment recommendations Time from admission to provision of a treatment recommendation following the low-dose CT / PoC-PCR results. throughout hospitalization, an average of 7 days
Secondary change in antibiotic consumption Whether changes were made in the antibiotic class during treatment throughout hospitalization, an average of 7 days
Secondary time to change in antibiotic consumption When changes were made in the antibiotic class during treatment throughout hospitalization, an average of 7 days
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