Reduction of antibiotic therapy by biomarkers in patients with CAP episodes

Completed

Conditions: Pneumonia
10004018
10024970

Registration Number: NL-OMON45194

Lead Sponsor: Medisch Centrum Alkmaar

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 468

Inclusion Criteria

Male and female patients with a diagnosis of CAP and all criteria listed below:
1. Age 18 or above, no upper age limit will be employed.
2. Patients must require hospitalisation.
3. Clinical presentation of an acute illness with one 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. Hemoptysis
f. Malaise or fatigue
g. Myalgia
h. Gastro-intestinal symptoms
i. Rales, rhonchi or wheezing
j. Egophony or bronchial breath sounds
4. New consolidation(s) on the chest radiograph.
5. Written informed consent obtained.
6. (Pre-event) Life expectancy > 30 days.

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 disease.
3. Obstruction pneumonia (e.g. from lung cancer).
4. Aspiration pneumonia.
5. Pneumonia that developed within 8 days after hospital discharge.
6. Unable and/or unlikely to comprehend and/or follow the protocol.
7. Pregnant and/or lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this study is to determine whether the CRP and PCT<br /><br>strategies can be used to safely and effectively reduce the duration of<br /><br>antibiotic treatment in patients with CAP requiring hospitalisation.<br /><br><br /><br>The diagnosis CAP will be made if a non-hospitalized person presents with one<br /><br>or more symptoms associated with a lower respiratory tract infection and a new<br /><br>infiltrate on the chest radiograph. These symptoms are: temperature greater<br /><br>than 38°C (100.4°F); cough with or without sputum; hemoptysis; pleuritic chest<br /><br>pain; dyspnea; malaise or fatigue; myalgia; gastro-intestinal symptoms; rales,<br /><br>rhonchi or wheezing; egophony or bronchial breath sounds. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives of this study are to assess the length of hospital<br /><br>stay, clinical response, 30-day mortality, time to clinical stability and<br /><br>relapse rate within 30 days. A relapse is defined as new or worsening symptoms<br /><br>indicative of pneumonia after initial improvement on therapy. Furthermore<br /><br>several biomarkers and genetic polymorfisms for corticosteroid-receptors will<br /><br>be assessed at the end of the study.</p><br>