Clinical trial NCT02274896: Bayston Multicenter Antimicrobial PD Catheter Safety Study
Official title: A Prospective Multicenter Investigation to Evaluate the Safety of the Bayston Antimicrobial Peritoneal Dialysis Catheter in ESRD Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: End Stage Renal Disease (ESRD)
Lead sponsor: Medical Components, Inc dba MedComp
Sponsor class: INDUSTRY
First posted: 2014-10-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 expected to cause any safety related complications or reactions other than those described for not-impregnated peritoneal dialysis catheters. Thus the objective of this clinical investigation is to evaluate whether the Bayston catheter causes any unanticipated serious adverse device effects (USADE).

The primary hypothesis for this study is that the Bayston Antimicrobial Peritoneal Dialysis Catheter is a safe catheter for peritoneal dialysis.

No claims regarding efficacy will be verified during this clinical investigation.

This is a prospective, non-randomized, single-arm, multi-center study involving patients suffering from end stage renal disease who are eligible for treatment with peritoneal dialysis. Forty-three (43) patients will be enrolled who will be followed up to 6 months after implantation of the Bayston Antimicrobial Peritoneal Dialysis Catheter.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Adverse events
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Bristol
country: United Kingdom
facility: North Bristol NHS Trust
city: London
country: United Kingdom
facility: Imperial College London - Hammersmith Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust - Northern General Hospital
Study officials:
affiliation: Renal consultant
name: Martin Wilkie, Dr.
role: PRINCIPAL_INVESTIGATOR
References: