A Phase 4 interventional study of antibiotic lock and conventional IP antibiotics in Peritoneal Dialysis-associated Peritonitis, sponsored by Alice Ho Miu Ling Nethersole Hospital. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by Alice Ho Miu Ling Nethersole Hospital · Phase 4, Interventional, and Treatment
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.
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. 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
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. 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.
167 studies on the registry are indexed under Peritonitis; 23 are open to participants now.
This study's planned enrollment of 46 is below the median of 79 across 106 interventional studies indexed under Peritonitis.
Browse Peritonitis studies →Alice Ho Miu Ling Nethersole Hospital is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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
Plan to share: No
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Alice Ho Miu Ling Nethersole Hospital