Bayston Multicenter Antimicrobial PD Catheter Safety Study (Bayston)

Inclusion Criteria:

• End stage renal disease documented by clinical symptoms and/or laboratory findings
• Patients scheduled for their first PD catheter implantation
• Eligible for peritoneal dialysis (CAPD)
• Willing and able to attend all study follow-up visits
• Willing and able to understand and sign the informed consent form

Exclusion Criteria:

• A history of allergy to rifampin, trimethoprim or triclosan
• Use contact lenses or have lens implants
• Pregnant, lactating or planning to become pregnant during the course of the clinical investigation
• Recent abdominal surgery, abdominal adhesions, infected abdominal wall, diaphragmatic tears or ileus
• Respiratory insufficiency

• Infection:

  • Active infections from successful completion of antibiotic treatment for routine bacterial infection less than 4 weeks of entry into the clinical investigation (screening)
  • Febrile viral infection within 4 weeks of entry into the clinical investigation (screening)
  • Less than 12 weeks from conclusion of therapy for systemic fungal infections to screening
• Abnormal hematology parameters defined as severe anemia with hemoglobin <8.5g/dL, white blood cell count of <3,500/μl and a granulocyte count <2,000/μl
• Have collagen-vascular, connective tissue, or bleeding disorders
• Used an investigational medicinal product, biologic or device within the last 30 days prior to enrollment