Using antibiotic-lock in Tenckhoff catheters to prevent repeat peritonitis
Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis
This study is testing if using an antibiotic-lock in Tenckhoff catheters can help prevent repeat peritonitis in patients on peritoneal dialysis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Alice Ho Miu Ling Nethersole Hospital Academic / other |
| Locations | 1 site (Tai Po) |
| Trial ID | NCT05971537 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of using an antibiotic-lock in Tenckhoff catheters to eradicate biofilm bacteria that cause relapsing and repeat peritonitis in patients undergoing peritoneal dialysis. The study will recruit 46 patients who have experienced peritonitis and will randomly assign them to either receive the antibiotic-lock treatment or continue with conventional intraperitoneal antibiotics. The goal is to determine if the antibiotic-lock can prevent future episodes of peritonitis without the need for catheter removal. The study will closely monitor patients for their response to treatment and the presence of bacteria in the peritoneal dialysis effluent.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced relapsing or repeat peritonitis with the same causative organism within a specified timeframe.
Not a fit: Patients who do not respond to appropriate intraperitoneal antibiotics or have fungal or mycobacterial peritonitis will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the need for catheter removal and improve the quality of life for patients with peritoneal dialysis.
How similar studies have performed: While the use of antibiotic-locks has shown success in hemodialysis, this approach in peritoneal dialysis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PD patients who suffer from Either relapsing peritonitis (within 4 weeks of completion of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of antibiotics), in which the causative organism is confirmed to be identical to the one in the preceding peritonitis episode, or Persistent growth of bacteria from PD effluent (PDE) after completion of standard 2-week antibiotic treatment, despite the resolution of symptoms and PDE leukocyte count \<100/mm3 * Age \> 18 years old * informed consent available Exclusion Criteria: * Patients who do not respond to the appropriate IP antibiotics, evident by the persistence of peritonitis symptoms in which they should be referred for timely Tenchkoff catheter removal * Fungal or mycobacterial PD peritonitis * Co-existing exit site or tunnel tract infection * The presence of Tenckhoff catheter drainage dysfunction * \<= 3 years old * Pregnant patients
Where this trial is running
Tai Po
- Alice Ho Miu Ling Nethersole Hospital — Tai Po, Hong Kong (Recruiting)
Study contacts
- Principal investigator: ping kwan chan — Alice Ho Miu Ling Nethersole Hospital
- Study coordinator: Ping Kwan Chan
- Email: cpk618a@ha.org.hk
- Phone: 26892000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.