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

Primary Purpose

Peritoneal Dialysis-associated Peritonitis

Status
Recruiting
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
antibiotic lock
conventional IP antibiotics
Sponsored by
Alice Ho Miu Ling Nethersole Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Dialysis-associated Peritonitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Alice Ho Miu Ling Nethersole HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

intervention arm

control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2023
Last Updated
July 25, 2023
Sponsor
Alice Ho Miu Ling Nethersole Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05971537
Brief Title
Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis
Official Title
Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alice Ho Miu Ling Nethersole Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.
Detailed Description
STUDY OBJECTIVES This study aims to evaluate whether the use of antibiotic-lock in the Tenckhoff catheter can eradicate the biofilm within the catheter lumen, thereby preventing further episodes of relapsing of repeat peritonitis without catheter removal. METHODS Total 46 patients are to be recruited When a PD patient, who has an episode of peritonitis treated successfully by IP antibiotics within the preceding 12 weeks, returns to the investigator's unit for peritonitis, the patient will be resumed on the same IP antibiotics treatment as in the last episode, while waiting for the PD effluent culture results. In the investigators' experience, the turnaround time of the microbiology report is usually 3-5 days. During this period, the patient should be closely monitored for the response to the antibiotics. The patient will be eligible for recruitment into this study if the same causative organism is confirmed subsequently. Another scenario is the absence of peritonitis symptoms, including PDE leukocyte count <100/mm3, yet there is a persistent growth of bacteria from the PDE after completion of 2-week antibiotic therapy. These patients are also eligible for study recruitment. After recruitment, the subject will be randomized into either the intervention arm or the control arm in a 1:1 manner. 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 (1). In the case of persistent bacterial growth from PDE without peritonitis symptoms, IP antibiotics will be extended up to 2 weeks more. In the intervention arm, in addition to the appropriate IP antibiotics, an antibiotic-lock will be prepared by the same antibiotics. The investigators will follow the suggested data used in hemodialysis catheter for the concentration of different antibiotics to prepare the locking solution (2) All antibiotics are diluted into an appropriate amount of normal saline or water to achieve the desired concentration. The resulting locking solution will be instilled precisely to fill up the Tenckhoff catheter and the transfer set once a day by the renal nurses. 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 (3). 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. RANDOMIZATION Randomization is carried out by drawing a consecutively numbered, sealed, opaque envelope containing a form indicating whether the subject is randomized into the intervention arm or control arm. STUDY PARAMETERS The patients' demographics, including the age, gender, body mass index, PD vintage, etiology of end-stage renal disease, co-morbidities, together with the previous PD peritonitis history will be retrieved. The causative organisms of the current relapsing or repeat peritonitis are recorded. After recruitment into the study and the peritonitis episode has been cured successfully, all subjects will be followed for up to 6 months after completion of their IP antibiotics treatment. TERMINATION OF STUDY The subjects will be out from the trial when they have completed the study, or before the end of the study if their peritonitis is refractory to appropriate IP antibiotics rendering a need of timely Tenckhoff catheter removal, or at anytime the subjects decide to withdraw from the trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis-associated Peritonitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control arm
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
antibiotic lock
Intervention Description
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 Type
Drug
Intervention Name(s)
conventional IP antibiotics
Intervention Description
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
Primary Outcome Measure Information:
Title
developement of relapsing or repeat peritonitis
Description
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 Outcome Measure Information:
Title
development of peritonitis due to same organism, beyond 12 weeks
Description
Development of peritonitis due to the same organism, beyond 12 weeks of completion of antibiotics
Time Frame
6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Kwan Chan
Phone
26892000
Email
cpk618a@ha.org.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ping kwan chan
Organizational Affiliation
Alice Ho Miu Ling Nethersole Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alice Ho Miu Ling Nethersole Hospital
City
Tai Po
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ping kwan chan
Phone
26892000
Email
cpk618a@ha.org.hk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27282851
Citation
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. Erratum In: Perit Dial Int. 2018 Jul-Aug;38(4):313.
Results Reference
background
PubMed Identifier
25548523
Citation
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.
Results Reference
background
PubMed Identifier
30858288
Citation
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.
Results Reference
background

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

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