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

ConditionPeritoneal Dialysis-associated 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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

antibiotic lock
Drug
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
conventional IP antibiotics
Drug
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

Treatment groups

46 Participants

are divided into 2 treatment groups

Group A: intervention armActive comparator 1 intervention

Group B: control armOther 1 intervention

Trial outcomes

Primary outcomes

rate of developement of relapsing or repeat peritonitis

Development of relapsing peritonitis (within 4 weeks of completion of antibiotics) or repeat peritonitis (between 4 to 12 weeks of completion of antibiotics) again

Time frame

6 month

Secondary outcomes

rate of development of peritonitis due to same organism, beyond 12 weeks

Development of peritonitis due to the same organism, beyond 12 weeks of completion of antibiotics

Time frame

6 month

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alice Ho Miu Ling Nethersole Hospital

Lead sponsor

Source ClinicalTrials.gov

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