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…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
- Number of days of treatment with any antibiotics during index admission,
including antibiotic prescriptions provided at discharge;
- Number of days hospitalized during the index hospitalization;
- Occurrence of ICU admission during the index hospitalization;
- Occurrence of in-hospital mortality during the index hospitalization;
- Occurrence of readmissions after the index admission within 30 days of the
index admission;
- Time from admission to availability of the low-dose CT results;
- Time from admission to provision of a treatment recommendation following the
low-dose CT results;
- Proportion of patients changing the diagnosis based on low-dose CT results;
- Time from admission to change in diagnosis based on low-dose CT results;
- Time from presenting at the ER to availability of the PoC-PCR test results;
- Time from presenting at the ER to provision of a treatment recommendation
following the PoC-PCR test results;
- Proportion of patients changing from empirical to or started on targeted
antibiotic treatment based on PoC-PCR results;
- Proportion of patients stopping empirical antibiotic treatment early (within
72 hours) based on PoC-PCR results;
- Time from admission to targeted antibiotic treatment or early termination
based on the PoC-PCR results;
Background summary
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 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.
Study 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.
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.
Study burden and risks
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.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Being aged 18 years or above;
- Having a working diagnosis of CAP at the emergency department with the
presence of at least two of the clinical criteria (below)* 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., * Clinical criteria
include:
* New or worsened coughing;
* Production of purulent sputum or change in character of sputum;
* Temperature > 38°C or <<= 36.0°C;
* Auscultatory findings consistent with pneumonia, including rales, evidence of
pulmonary consolidation (dullness on percussion, bronchial breath sounds, or
egophony), or both;
* White blood cell count of >10×10^9 cells/L or <4x10^9 cells/L or >15% bands
* C-reactive protein level ><= 30 mg/L;
* Dyspnea, tachypnea (> 20 breaths per minute), or hypoxaemia (arterial pO2 <60
mmHg or peripheral O2 saturation < 90%).
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, defined as having one or more of the following
criteria:
* HIV infection with a last CD4 count of <300/*L;
* Cytotoxic chemotherapy or radiotherapy in the previous 3 months;
* Chronic hemodialysis > 3 months;
* History of receiving an organ or bone marrow transplant;
* Using immunosuppressive therapy. This includes corticosteroid treatment only
when dosage is high (>0,5mg/kg/day) for a longer period of time (>14 days).
* History of primary immunocompromising conditions
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT03360851 |
| CCMO | NL61857.041.17 |