Dexamethasone in community-acquired pneumonia.

Santeon-CAP study Dexamethasone in community-acquired pneumonia. - Santeon-CAP study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004566-14-NL

Enrollment

600

Registered

2012-01-09

Start date

2012-01-09

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a community-acquired pneumonia who are admitted to the hospital.

Interventions

Trade Name: dexamethasone tablet 1,5 mg Product Name: Dexamethasone Pharmaceutical Form: Tablet CAS Number: 50-02-2 Other descriptive na

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged 18 to 100 years with a community-acquired pneumonia which requires admission. Criteria to determine a community-acquired pneumonia: - Chest radiograph showing new opacities. In combination with two of the following findings: 0 Cough 0 Production of sputum 0 Temp >38,0 °C or 10.000 cells/mm3), leftward shift (>10%) or leucopenia ( 15 mg/l (three fold higher than the upper limit of normal) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 300

Exclusion criteria

Exclusion criteria: - Immunocompromised patients: 0 Patients with a known congenital or acquired immunodeficiency. 0 Patients who received chemotherapy less than 6 weeks ago. 0 Patients who received corticosteroids in the last 6 weeks. 0 Patients who received immunosuppressive medication in the last 6 weeks (e.g. cyclosporin, cyclophosphamide, azathioprine). 0 Patients with COPD who are on systemic corticosteroids for COPD. - Patients who require ICU treatment. - Patients with tropical worm infection. - Patients with dexamethasone intolerance. - Pregnant and breastfeeding women.

Design outcomes

Primary

Measure	Time frame
Main Objective: The effect of dexamethasone on clinical outcome in patients admitted with CAP; Primary end point(s): Length of hospital stay. ;Timepoint(s) of evaluation of this end point: When all 600 patients are included.; Secondary Objective: Study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis based on: o disease severity score (PSI 1-3 vs. PSI 4-5); o CRP level at admission; o causative microorganism (Pneumococcus antigentest positive vs. negative); o cytokine response (IL-6 and IL-10) over time; o cortisol level over time; o procalcitonin over time.	—

Measure

Time frame

Main Objective: The effect of dexamethasone on clinical outcome in patients admitted with CAP; Primary end point(s): Length of hospital stay. ;Timepoint(s) of evaluation of this end point: When all 600 patients are included.; Secondary Objective: Study what patients admitted with CAP benefit most from dexamethasone therapy. Predefined subgroup analysis based on: o disease severity score (PSI 1-3 vs. PSI 4-5); o CRP level at admission; o causative microorganism (Pneumococcus antigentest positive vs. negative); o cytokine response (IL-6 and IL-10) over time; o cortisol level over time; o procalcitonin over time.

—

Secondary

Measure	Time frame
Secondary end point(s): - in-hospital mortality - one-year mortality ;Timepoint(s) of evaluation of this end point: When all 600 patients are included.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026