Relation between biomarkers and new radiographic abnormalities in patients hospitalized with Community Acquired Pneumonia

Recruiting

Conditions: Pneumonia
10019815
10024970

Registration Number: NL-OMON45017

Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 44

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Presence of infiltrates on low-dose CT-scan.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary efficacy analysis as follows:<br /><br>Mean biomarker levels between groups with a positive CT-scan versus a negative<br /><br>CT-scan. Mean level of biomarker will be assessed by a student T-test if<br /><br>normally distributed or by Mann-Whitney U test if not normally distributed.<br /><br>The amount of abnormalities on CT-scan will be correlated with the levels of<br /><br>biomarkers by a Spearman or Pearson analysis.<br /><br>We will try to determine if there*s a relation between duration of symptoms and<br /><br>the chance of a positive CT-scan. This will be done by a binary logistic<br /><br>regression for the outcome yes/no. And by linear regression for duration of<br /><br>symptoms versus the amount of abnormalities on CT-scan.</p><br>