Relative adrenal insufficiency in children with pneumonia and sepsis. Efficacy of i.v. prednisolon for prevention of complication of pneumonia. A prospective, parallel-group, randomised trial.
- Conditions
- Severe complications of bacterial pneumonia i.e. abscess formation, empyema and sepsis in children. Supposed concomittant andrenal insuficiency is also planned to investigate.
- Registration Number
- EUCTR2007-006602-24-HU
- Lead Sponsor
- Department of Pediatrics, Medical and Health Science Center, University of Debrecen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Male and female inpatients
Age 2-17 years
Severe bacterial pneumonia (typical clinical and radiological features)
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Severe concomittant disease, i.e. immunodeficiency, malignant disease, cystic fibrosis, primary ciliary dyskinesis, etc.
Clincally significant lab result indicating unknown other disease
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Efficacy of i.v. corticosteroid and i.v. antibiotic treatment of children with severe bacterial pneumonia and sepsis compared to efficacy of antiotic treatment only considering the duration of disease process.;Secondary Objective: Number of days with septic symptoms<br>Manifestetion of complications and their duration<br>Lab findings of adrenal insufficiency<br>Side effects;Primary end point(s): Shorter disease process without or minimal complications of severe bacterial pneumonia in children.
- Secondary Outcome Measures
Name Time Method