Severe complications of bacterial pneumonia i.e. abscess formation, empyema and sepsis in children. Supposed concomittant andrenal insuficiency is also planned to investigate.
Conditions
Interventions
Trade Name: Di-Adreson F Aquosum
Pharmaceutical Form: Injection*
Sponsors
Department of Pediatrics, Medical and Health Science Center, University of Debrecen
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: Severe concomittant disease, i.e. immunodeficiency, malignant disease, cystic fibrosis, primary ciliary dyskinesis, etc. Clincally significant lab result indicating unknown other disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Manifestetion of complications and their duration Lab findings of adrenal insufficiency Side effects;Primary end point(s): Shorter disease process without or minimal complications of severe bacterial pneumonia in children. | — |
Countries
Hungary
Outcome results
None listed