A prospective randomized study of antibiotic prophylaxis for renal transplantation: short term vs standard treatment - ND

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004284-21-IT

Enrollment

120

Registered

2008-01-04

Start date

2007-07-06

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

antibiotic prophylaxis for renal tranplantation MedDRA version: 9.1 Level: LLT Classification code 10038533 Term: Renal transplant

Interventions

Trade Name: CEFAZOLINA TEVA Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Cefazolin Concentration unit: g gram(s) Concentration type: equal Concentration numb

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: renal transplantation - age 18-65 years 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: increased risk for infections for diabetes, BMI >30Kg/m2,WBC 65 years and <18years

Design outcomes

Primary

Measure	Time frame
Main Objective: Superiority of single dose - same incidence of infectious complications;Secondary Objective: Incidence of infections - use of antibiotics (dose and days of treatment) - mean hospitalization;Primary end point(s): low incidence of infections - low toxicity - low costs	—

Countries

Italy

Outcome results

None listed

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