1. To assess the incidence of pulmonary infiltrates by means of low dose CT-scan in patients with a high clinical suspicion of CAP but with a normal chest x-ray 2. The levels of biomarkers (CRP, PCT, White blood cell count) will be compared to the…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Presence of infiltrates on low-dose CT-scan.
Secondary outcome
Secondary efficacy analysis as follows:
Mean biomarker levels between groups with a positive CT-scan versus a negative
CT-scan. Mean level of biomarker will be assessed by a student T-test if
normally distributed or by Mann-Whitney U test if not normally distributed.
The amount of abnormalities on CT-scan will be correlated with the levels of
biomarkers by a Spearman or Pearson analysis.
We will try to determine if there*s a relation between duration of symptoms and
the chance of a positive CT-scan. This will be done by a binary logistic
regression for the outcome yes/no. And by linear regression for duration of
symptoms versus the amount of abnormalities on CT-scan.
Background summary
Pneumonia is possibly under diagnosed in patients presenting to an ER. This due
limitations of the chest X-ray. Consequently the true incidence of Community
Acquired pneumonia remains unknown. Symptoms and physical findings are
non-specific and infiltrates aren't always visible on the chest X-ray.
Low-dose CT-scans might be useful in distinguishing patients with CAP from
those with bronchitis. We believe low-dose CT-scans will prove to be more
accurate in diagnosing CAP than the chest X-ray. A pulmonary infiltrate on
low-dose CT-scan in combination with elevated biomarkers associated with
infection/inflammation might prove the most viable way to diagnose CAP. This
combination could also prove useful in distinguishing bacterial from viral
infections. Subsequently this might lead to changes in current diagnostic en
therapeutic regimes.
Study objective
1. To assess the incidence of pulmonary infiltrates by means of low
dose CT-scan in patients with a high clinical suspicion of CAP but with a
normal chest x-ray
2. The levels of biomarkers (CRP, PCT, White blood cell count) will
be compared to the existence of infiltrates on the low dose CT-scan.
3. The extent of infiltrates will be measured and compared to the
level of biomarkers.
Study design
Patients admitted to the emergency ward with a high clinical suspicion of CAP
but a clean chest x-ray will be asked to participate. After obtaining informed
consent a low dose CT-scan will be performed and compared to biomarkers and
findings of the chest x-ray. The study is of an exploratory nature, therefore
44 patients will be asked to participate.
Study burden and risks
Slightly elevated exposure to radiation
It takes about 15 minutes to perform a CT-scan.
Koning Davidstraat 129
Zaandam 1502NX
NL
Koning Davidstraat 129
Zaandam 1502NX
NL
Listed location countries
Age
Inclusion criteria
Male and female patients with a high clinical suspicion of CAP and all criteria listed below:
1. Age 18 or above, no upper age limit will be employed.
2. Clinical presentation of an acute illness with two or more of the following symptoms:
a. Temperature * 38.0 *C (100.4°F)
b. Dyspnoea
c. Cough (with or without expectoration of sputum)
d. Chest pain
e. Rales, rhonchi or wheezing
f. Egophony or bronchial breath sounds
3. No consolidation(s) on the chest radiograph.
4. Written informed consent obtained from the patient or a family member.
Exclusion criteria
Subjects presenting with any of the following will not be included in the study:
1. Severe immunosuppression (HIV infection, chemotherapy).
2. Active neoplastic lung disease.
3. Obstruction pneumonia (e.g. from lung cancer).
4. Pneumonia that developed within 8 days after hospital discharge.
5. Unable and/or unlikely to comprehend and/or follow the protocol.
6. Pregnant and/or lactating women.
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 |
|---|---|
| CCMO | NL51063.094.14 |