Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02467192 |
| Other study ID # |
14-250 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2015 |
| Est. completion date |
May 1, 2017 |
Study information
| Verified date |
October 2021 |
| Source |
University Hospital, Geneva |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Diagnosis of pneumonia in the elderly is difficult because of the poor sensitivity and
specificity of clinical signs as well as images from chest radiography (RT). New diagnostic
tools such as thoracic low-dose computed tomography (CT), which exposes the patient to a weak
dose of irradiation, could improve diagnosis. Moreover, low-dose CT could provide additional
accuracy in the etiological clarification of pneumonia in elderly people.
As a first step, the investigators aim to perform a 1 year (12 months of inclusion + 3 months
of follow-up) prospective study including the Divisions of Internal Medicine, Rehabilitation,
Geriatrics and Radiology of the University Hospitals of Geneva. In this study, patients >65
years old with a clinical suspicion of low respiratory tract infection (LRTI) will be
included. They will be prescribed antimicrobial therapy. Both chest radiography and low-dose
thoracic CT will be performed within the first 72 hours after admission, as will blood tests
and a nasopharyngeal swab.
The clinician's diagnosis, both before and after the results of the CT, will be compared at
the end of the study to the adjudication committee's diagnostic opinion which will have
access to all available clinical, laboratory and chest X-ray data and which will be
considered the gold standard. At the end of the study, all the CT images will be
blind-reviewed by two experts in radiology. The impact of CT scanning in the diagnosis of
pneumonia will be assessed, both for its sensitivity and specificity in this population.
During the first 12 months of the study, all patients will undergo a systematic
nasopharyngeal swab at admission and at discharge, from which eluates will be conserved.
During the next 12 months, virological and bacteriological polymerase chain reactions (PCR)
will be performed, using new diagnostic tools, in order to determine the etiological
diagnosis in this population and to evaluate the impact of the new tools in the management of
pneumonia for this population.
Analysis of these data will allow clinical, radiological and microbiological correlation.
Description:
The project's principal aim is to assess the impact of low-dose CT scanning versus chest
radiography in the diagnosis of pneumonia in elderly patients.
One of the secondary objectives is to estimate sensitivity and specificity of CT scanning in
pneumonia diagnosis in the elderly (gold standard: adjudication committee advice).
This prospective study should be considered a preliminary feasibility study in preparation
for a future randomized clinical trial comparing patient management, antibiotic prescription
and clinical outcomes between one group of patients with LRTI randomized to routine thoracic
CT scan and one group randomized to usual care.
The second phase of this study will explore the etiologies of pneumonia in the elderly using
new diagnostic tools. This will lead to identify radiological patterns associated with
clinical presentation and microbiological results.
Primary objective: to estimate the impact of CT scanning in the diagnosis of pneumonia in
elderly patients, in a monocentric study (but within two sites, Service de Médecine Interne
Générale and Hôpital des Trois-Chêne).
Secondary objectives: to estimate sensitivity and specificity of CT scanning in pneumonia
diagnosis (gold standard: adjudication committee advice), and to identify microbiological
etiologies of pneumonia in the elderly.
Study-design: prospective interventional study.
Intervention:
Patients will be managed according to HUG guidelines. Frontal (and lateral if possible) chest
radiography (RT) will be interpreted by the physician; he will assess the level of certainty
for a diagnosis of pneumonia on a Likert scale, as well as its localization. Subsequently, a
thoracic CT scan will be performed within the first 48-72 hours of admission, with conclusion
by a radiologist (on a Likert scale). After the CT scan, the physician will get the result
and assess a new level of certainty of diagnosis (on a Likert scale). If the clinician
changes his therapy, this will be noted on the case report form (CRF).
Patients will undergo two nasopharyngeal swabs (on admission and discharge) for storage in a
biobank, and microbiological (bacteriological and viral) PCR will be performed at a later
date.
Patients will be followed until day 90. Information concerning rehospitalization and death
will be obtained by review of the patient's medical chart and the civil registry.
At the end of the study, chest radiographs (RT) and CT will be blinded-analyzed by two
referring radiologists (MS and XM).
An adjudication committee (one internist, one infectiologist, one pneumologist) will review
patients' data in order to provide a gold standard diagnosis which will be made according to
international guidelines (8, 9): clinical symptoms, recent new abnormalities on chest
radiograph and outcome under antimicrobial therapy.
After the end of the clinical study, the virology group will analyze the eluates from the
nasopharyngeal swabs using new PCR tests. After completing routine PCR (Adenovirus,
Bocavirus, Coronavirus, Enterovirus, Influenza A and B viruses, Parainfluenza virus,
Parechovirus, Picornavirus, Respiratory Syncytial Virus, Chlamydophila pneumoniae, Mycoplasma
pneumoniae), two different bacterial PCR kits will be used to test each eluate (admission and
discharge): the Fast Track Diagnostics (FTD) Bacterial pneumonia CAP (for Community Acquired
Pneumonia) kit (Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis,
Staphylococcus aureus, Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella spp) and the
FTD Bacterial pneumonia HAP (for Hospital Acquired Pneumonia) kit (Klebsiella pneumoniae,
Pseudomonas aeruginosa).
The expenses of additional examinations will not be charged to the patient or to his health
insurance company, but will be paid for by the HUG within the framework fixed price for
hospitalization.
Evaluation criteria:
- Assessments by the physician, before and after CT scanning, will be compared: number of
upgraded or downgraded diagnoses; sensitivity and specificity of chest radiography RT
and CT; correlation between the physician and the radiologist.
- Descriptions of the etiologies of pneumonia, with number of viral and bacterial
pneumonia.
- Clinical, radiological, microbiological correlations.
- Outcome (re-hospitalization, mortality) at 30 and 90 days.
Statistical considerations:
The investigators hypothesize that chest CT will upgrade the certainty of diagnosis in 19% of
cases (14). To significantly increase the level of diagnosis of pneumonia, 46 patients with
suspicion of pneumonia are needed (α = 0.05, β 0.1). The investigators estimate the rate of
pneumonia in this population to be 45% (15); this implies that 100 participants should be
enrolled in order to significantly increase the accuracy of diagnosis.
Inclusion in this study could begin in June 2015, for 12 months, with the last follow-up for
the last patient coming after a total of 15 months (12 months plus 90 days).
Anticipated results:
The investigators anticipated that low-dose CT scan will improve the diagnosis of pneumonia
in the elderly. The study's final objective is to prepare a second randomized study measuring
the impact of chest CT scans on the management of patients in two cohorts of patients - one
which only undergoes a chest X-ray, and one which only undergoes a CT scan - for assessing
diagnosis and treatment.
