12 Patients (full term neonates with 7 to 28 days of age) with infections of the skin, the nails or the respiratory tract.
Conditions
Interventions
Trade Name: Zinacef 250 mg
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Cefuroxim-Natrium
CAS Number: 56238632
Concentration unit: mg/ml milligram(s)/millilitre
Concentra
Sponsors
Universität Heidelberg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 12 Patients (full term neonates with 7 to 28 days of age) with infections of the skin, the nails or the respiratory tract. 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: Patients with known renal insufficiency or diseases with risk of impairment of renal function: Multicystic kidney disease, renal agenesy, hydronephrosis, subpelvine stenosis, urethral valve, vesico ureteral refluxe, acute renal failure, haemolytic uraemic syndrome, glomerulonephritis, nephrotoxic medication like cytostaticas or indomethacine, serum creatinine over 0.6 mg/dl.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigation of the intestinal resorption of cefuroxime-axetil in newborns. Recommendation of dosing based on serum concentrations.;Secondary Objective: Additional data about the pharmacokinetics, safety and tolerance of intravenous cefuroxime in term neonates. ;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed