Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlice Ho Miu Ling Nethersole Hospital
About this trial
Biofilm formation is an important cause of catheter-related infection. In hemodialysis, use of an antibiotic-lock has been proven to be effective to manage such a complication with preservation of the central venous catheter. In peritoneal dialysis, while biofilm has been implicated in relapsing and repeat peritonitis, both of which are caused by the identical bacteria as in their preceding peritonitis episode, no adjunctive measure has been proven to be effective to eradicate the biofilm bacteria. As a result, Tenckhoff catheter removal is the only recommended option for the patients suffering from relapsing or repeat peritonitis. In this study, the investigators are going to investigate whether the use of an antibiotic-lock can be useful to eradicate the biofilm in the Tenckhoff catheter to prevent future episodes of peritonitis caused by the same organism.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- antibiotic lock
- conventional IP antibiotics
Treatment groups
46 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov