Pneumonia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to determine whether the CRP and PCT strategies can be used to safely and effectively reduce the duration of antibiotic treatment in patients with CAP requiring hospitalisation. The diagnosis CAP will be made if a non-hospitalized person presents with one or more symptoms associated with a lower respiratory tract infection and a new infiltrate on the chest radiograph. These symptoms are: temperature greater than 38°C (100.4°F); cough with or without sputum; hemoptysis; pleuritic chest pain; dyspnea; malaise or fatigue; myalgia; gastro-intestinal symptoms; rales, rhonchi or wheezing; egophony or bronchial breath sounds. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this study are to assess the length of hospital stay, clinical response, 30-day mortality, time to clinical stability and relapse rate within 30 days. A relapse is defined as new or worsening symptoms indicative of pneumonia after initial improvement on therapy. Furthermore several biomarkers and genetic polymorfisms for corticosteroid-receptors will be assessed at the end of the study. | — |
Countries
Netherlands