An interventional study of low-dose CT and PoC-PCR in Community-acquired Pneumonia, sponsored by MJM Bonten. Terminated at 7 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-21.
Sponsored by MJM Bonten · Not applicable, Interventional, and Diagnostic
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Among 16 studies in Community-Acquired Pneumonia with a site in Netherlands — 2 open to participants now, 2 under way, 2 of them phase 3. Community-Acquired Pneumonia · Netherlands.
Among the 16 studies in Community-Acquired Pneumonia with a site in Netherlands, this one is the 4th largest by enrollment of the 13 interventional ones that give a count, is the only one that started in 2017, is one of 6 with no phase, and was the 14th registered.
325 studies on the registry are indexed under Community-Acquired Pneumonia; 78 are open to participants now.
Browse Community-Acquired Pneumonia studies →2 of the 16 studies in Community-Acquired Pneumonia with a site in Netherlands are open now. Recruiting first, the newest first:
University of Oxford · Sites in Netherlands, Belgium, Estonia and 13 more countries
Ages 0+
UMC Utrecht · Sites in Netherlands, United States, Australia and 26 more countries
Ages 28 days+
A study can be open while its sites in Netherlands have not opened yet or have stopped. Only those recruiting at a site in Netherlands →
Of the 41 Community-Acquired Pneumonia studies recruiting now, 29 (71%) set no upper age limit and 9 (22%) stop at 75 or younger; 13 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3,555 is above the median of 246 across 196 interventional studies indexed under Community-Acquired Pneumonia.
Median enrollment 738 across the 13 interventional studies, 4,035 across the 3 observational. Of the 14 that completed or were terminated, 1 (7%) have results posted.
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4 of 16 have an industry lead sponsor. The 10 most frequent:
MJM Bonten is the lead sponsor of 5 studies on the registry; none are open to participants now.
MJM Bonten has 1 study filed under Community-Acquired Pneumonia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Community-Acquired Pneumonia with a site in Netherlands, from their registry updates:
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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.
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Exclusion Criteria:
A low-dose chest CT-scan will be performed either directly from the ER or from the medical ward as soon as possible but within 24 hours of admission. The CT will be performed with a radiation dose \<0.5 mSv for a 70kg patient, as a replacement or in addition to the chest radiograph. Pregnancy will be an exclusion criterion for CT because of unwanted radiation exposure. CT interpretation will be performed by a radiologist. Test results will be communicated to the treating physician. Recommendations based on the CT may be to discontinue antibiotics in case of a noninfectious diagnosis that explains the presented signs and symptoms and to start treatment for the alternative diagnosis if needed, or to re-evaluate the CAP diagnosis if no signs of lobar or bronchopneumonia are detected on the CT.
Diagnostic Test: low-dose CT
The FilmArray real-time multiplex PCR (Biofire; bioMérieux) is a Point-of-Care PCR with a panel of respiratory viruses (adenovirus, coronavirus, human metapneumovirus, human rhinovirus/enterovirus, influenza A and B, parainfluenza virus, and respiratory syncytial virus), and three atypical pathogens (Mycoplasma pneumoniae, Chlamydophila pneumoniae, and Bordetella pertussis), which will be performed on nasopharyngeal swab samples. Test results will be made available to the treating physician immediately. The treatment recommendation could be adaptation of antibiotic treatment for a documented atypical pathogen, a recommendation to not start or discontinue antibiotics when a virus is the only detected pathogen, or a recommendation to discontinue coverage of atypical pathogens.
Diagnostic Test: PoC-PCR
All hospitals will continue the antibiotic stewardship activities employed during the baseline period as part of standard care. A representative of the Antibiotics-team (Team consisting of clinical microbiologists, infectious diseases specialist and clinical pharmacists supervising in-hospital antibiotic use) will monitor the empirical antibiotic treatment of patients hospitalized with CAP to non-ICU wards and provide feedback if indicated.
see arm/group description
see arm/group description
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.
Time frame: throughout hospitalization, an average of 7 days
All-cause mortality
All-cause mortality within 90 days of admission.
Time frame: 90 days
days of therapy with any antibiotic
Number of days of treatment with any antibiotics during index admission, including antibiotic prescriptions provided at discharge.
Time frame: throughout hospitalization, an average of 7 days
all-cause mortality
Time frame: 30 days
length of hospital stay
Time frame: throughout hospitalization, an average of 7 days
adverse outcomes
Composite endpoint comprising ICU admission, in-hospital mortality, and readmission
Time frame: 90 days
time to results
Time from admission to availability of the low-dose CT / PoC-PCR results.
Time frame: throughout hospitalization, an average of 7 days
time to treatment recommendations
Time from admission to provision of a treatment recommendation following the low-dose CT / PoC-PCR results.
Time frame: throughout hospitalization, an average of 7 days
change in antibiotic consumption
Whether changes were made in the antibiotic class during treatment
Time frame: throughout hospitalization, an average of 7 days
time to change in antibiotic consumption
When changes were made in the antibiotic class during treatment
Time frame: throughout hospitalization, an average of 7 days
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Jun 2020, 30 months.
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This study is terminated, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Community-Acquired Pneumonia →
MJM Bonten