Actively Recruiting

Phase 4
Age: 18Years +
All Genders
Healthy Volunteers
ID05971537

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

Led by Alice Ho Miu Ling Nethersole Hospital · Updated on 2024-01-31

46

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research investigates whether using an antibiotic-lock in the Tenckhoff catheter can remove biofilm bacteria that cause relapsing or repeat peritonitis in patients undergoing peritoneal dialysis. Biofilm has been linked to repeated infections caused by the same bacteria, and currently, catheter removal is the only recommended solution. The study aims to find if antibiotic-lock can prevent future infections without removing the catheter. Participants will be randomly assigned to one of two groups. The intervention group receives both standard intraperitoneal (IP) antibiotics and a daily antibiotic-lock solution instilled into the Tenckhoff catheter for 6 hours each day until the antibiotic course ends. The control group receives only the standard IP antibiotics following current guidelines. If participants in the control group meet specific criteria, they will crossover to receive the antibiotic-lock treatment. The antibiotic-lock solution is prepared with concentrations based on treatments used for hemodialysis catheters. Participants will be closely monitored during their infection treatment, including demographic and medical history collection, and followed for 6 months after completing antibiotics. The main outcome measured is the rate of developing relapsing or repeat peritonitis within 6 months. Secondary outcomes include infections caused by the same bacteria beyond 12 weeks. The study allows withdrawal at any time and will end early if catheter removal is needed due to antibiotic failure.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • PD patients with relapsing peritonitis within 4 weeks of antibiotic completion or repeat peritonitis between 4 to 12 weeks with the same causative organism
  • Persistent bacterial growth from PD effluent after standard 2-week antibiotic treatment despite symptom resolution and PDE leukocyte count <100/mm3
  • Age over 18 years
  • Informed consent provided
Not Eligible

You will not qualify if you...

  • Patients not responding to appropriate IP antibiotics requiring timely Tenckhoff catheter removal
  • Fungal or mycobacterial PD peritonitis
  • Co-existing exit site or tunnel tract infection
  • Tenckhoff catheter drainage dysfunction
  • Age 3 years or younger
  • Pregnant patients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Duration of IP antibiotics treatment, including possible extension up to 2 additional weeks

Participants receive intraperitoneal (IP) antibiotics to treat peritonitis. Those in the intervention arm also receive a daily antibiotic-lock instilled into the Tenckhoff catheter to eradicate biofilm and prevent relapse or repeat peritonitis. The antibiotic-lock solution dwells in the catheter for 6 hours each day while the abdomen is kept dry. The treatment duration follows the recommended course of IP antibiotics, including possible extension by up to 2 weeks if persistent bacterial growth is detected without symptoms.

Daily visits for antibiotic-lock instillation and monitoring during treatment period

Follow-up

Duration - Up to 6 months

After successful treatment of peritonitis, participants are followed for up to 6 months to monitor for relapse or repeat peritonitis and assess long-term outcomes.

Periodic visits during 6-month follow-up

Trial Site Locations

Total: 1 location

1

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Actively Recruiting

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Research Team

P

Ping Kwan Chan

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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