Pharmacokinetics of oral cefuroxime-axetil compared to intravenous cefuroxime in term neonates and possible adjustment of the oral therapy - Pharmacokinetics of oral cefuroxime-axetil in term neonates

Phase 1

Active, not recruiting

• Conditions: 12 Patients (full term neonates with 7 to 28 days of age) with infections of the skin, the nails or the respiratory tract.

• Registration Number: EUCTR2005-004151-35-DE
• Lead Sponsor: niversität Heidelberg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-14
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 12

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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):