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Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis

NCT05971537 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2024-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Peritoneal Dialysis-associated Peritonitis

Interventions

DRUG

antibiotic lock

In the intervention arm, in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. We will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution . Some commonly used antibiotics for the treatment of PD peritonitis with their suggested concentrations in the antibiotic-lock are quoted as below: Cefazolin 10mg/mL Ceftazidime 10mg/mL Vancomycin 10mg/mL Gentamicin 5mg/mL Tienam 50mg/mL

DRUG

conventional IP antibiotics

In the control arm, appropriate IP antibiotics are to be continued. The dosage and duration of antibiotics will fully follow the recommendation from the latest International Society for Peritoneal Dialysis (ISPD) peritonitis guidelines

Sponsors & Collaborators

  • Alice Ho Miu Ling Nethersole Hospital

    lead OTHER

Principal Investigators

  • ping kwan chan · Alice Ho Miu Ling Nethersole Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-06-15
Primary Completion
2026-10-31
Completion
2026-10-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05971537 on ClinicalTrials.gov