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

NCT05971537 | Recruiting Phase 4

• 1 other identifier: 2016.513-T
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  6 month

Secondary Outcomes (1)

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

  6 month

Study Arms (2)

intervention arm

ACTIVE COMPARATOR

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 The resulting locking solution will be instilled precisely to fill up the Tenckhoff catheter and the transfer set once a day. Prior to that, the existing PD solution is drained out first. As such, a "dry abdomen" is maintained during antibiotic-lock dwelling in the Tenckhoff catheter. This is to ensure the antibiotic-lock solution can be maintained within the catheter lumen for a prolonged period of time After a 6-hour dwell, the antibiotic-lock is drained out and usual PD schedule is resumed. Such a daily application of antibiotic lock shall last until the course of IP antibiotics is completed.

Drug: antibiotic lock

control arm

OTHER

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 \*For the subjects in the control arm who reach the defined primary end-point, they will automatically undergo crossover to the intervention arm to receive standard IP antibiotics together with the intra-catheter antibiotic-lock. They will be followed for another 6 months subsequently.

Drug: conventional IP antibiotics

Interventions

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

intervention arm

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

control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alice Ho Miu Ling Nethersole Hospital: lead

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

RECRUITING

Related Publications (3)

• Li PK, Szeto CC, Piraino B, de Arteaga J, Fan S, Figueiredo AE, Fish DN, Goffin E, Kim YL, Salzer W, Struijk DG, Teitelbaum I, Johnson DW. ISPD Peritonitis Recommendations: 2016 Update on Prevention and Treatment. Perit Dial Int. 2016 Sep 10;36(5):481-508. doi: 10.3747/pdi.2016.00078. Epub 2016 Jun 9. No abstract available.

  PMID: 27282851 BACKGROUND

• Justo JA, Bookstaver PB. Antibiotic lock therapy: review of technique and logistical challenges. Infect Drug Resist. 2014 Dec 12;7:343-63. doi: 10.2147/IDR.S51388. eCollection 2014.

  PMID: 25548523 BACKGROUND

• Wong SS, Lau WY, Chan PK, Wan CK, Cheng YL. Extended Experience in the Use of Antibiotic Lock for Eradication of Biofilm Bacteria on Tenckhoff Catheter. Perit Dial Int. 2019 Mar-Apr;39(2):187-190. doi: 10.3747/pdi.2018.00098.

  PMID: 30858288 BACKGROUND

Study Officials

• ping kwan chan

  Alice Ho Miu Ling Nethersole Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ping Kwan Chan

CONTACT

26892000; cpk618a@ha.org.hk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant, Department of Medicine

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: August 2, 2023
• Study Start: June 15, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)