Bayston Multicenter Antimicrobial PD Catheter Safety Study

NCT02274896 | Withdrawn DMC

• 1 other identifier: BAYPDC-14-01
• Study Type: interventional
• Target: N/A
• Locations: 3 countries
• Sites: 5

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

Conditions

End Stage Renal Disease (ESRD)

Outcome Measures

Primary Outcomes (1)

• Number of Adverse events

  Safety: Freedom from unanticipated serious device related adverse events up to 6 months after implantation of the Bayston catheter.

  6 months

Study Arms (1)

PD catheter group

EXPERIMENTAL

All patients will receive the Bayston PD catheter

Device: PD Catheter group

Interventions

PD Catheter group DEVICE

PD catheter

PD catheter group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Components, Inc dba MedComp: lead

Study Sites (5)

UZ Leuven

Leuven, Belgium

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

North Bristol NHS Trust

Bristol, United Kingdom

Location

Imperial College London - Hammersmith Hospital

London, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Martin Wilkie, Dr.

  Renal consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 24, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

NL (1); BE (1); GB (3)