Status:
WITHDRAWN
Bayston Multicenter Antimicrobial PD Catheter Safety Study
Lead Sponsor:
Medical Components, Inc dba MedComp
Conditions:
End Stage Renal Disease (ESRD)
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The study was designed to establish the safety of the Bayston Antimicrobial PD catheter that is impregnated with a "cocktail" of three well known anti-microbials
Detailed Description
The objective of this clinical investigation is to establish the safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD patients initiating CAPD. The Bayston catheter is not expecte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02274896
Start Date
November 1 2014
End Date
December 1 2015
Last Update
September 15 2022
Active Locations (5)
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1
UZ Leuven
Leuven, Belgium
2
University Medical Center Utrecht
Utrecht, Netherlands
3
North Bristol NHS Trust
Bristol, United Kingdom
4
Imperial College London - Hammersmith Hospital
London, United Kingdom