A prospective randomized study of antibiotic prophylaxis for renal transplantation: short term vs standard treatment - ND
- Conditions
- antibiotic prophylaxis for renal tranplantationMedDRA version: 9.1Level: LLTClassification code 10038533Term: Renal transplant
- Registration Number
- EUCTR2007-004284-21-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
increased risk for infections for diabetes, BMI >30Kg/m2,WBC < 3500, age>65 years and <18years
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method