IV Antibiotics With Lavage for Severe PD Peritonitis

Overview

This is a randomized controlled trial to evaluate whether a switch to intravenous antibiotics with adjunctive lavage can improve the outcome of severe peritoneal dialysis related peritonitis.

Full Title of Study: “Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2017

Detailed Description

The standard treatment of peritoneal dialysis (PD) related peritonitis is intraperitoneal (IP) antibiotics. In severe cases not responding to the IP antibiotics treatment, timely Tenckhoff catheter removal is needed. There is no known adjunctive measure that can improve the clinical outcome of the patients suffering from severe PD peritonitis. Based on the past experience in the investigators' center, switching IP to intravenous route of antibiotics administration, together with adjunctive lavage was proposed to improve the clinical outcome of severe PD peritonitis, in particular a possible improved catheter salvage rate. This method will be evaluated in the present clinical trial.

Interventions

  • Drug: Intravenous vancomycin & gentamicin with adjunctive lavage
    • Intravenous vancomycin and gentamicin are administered, together with adjunctive lavage performed by automated peritoneal dialysis machine over 48 to 72 hours. (choice of antibiotic is adjusted in accordance with the microbiology report when available)
  • Drug: Intraperitoneal vancomycin & gentamicin
    • Intraperitoneal vancomycin and gentamicin are administered, with the usual continuous ambulatory peritoneal dialysis schedule maintained. (choice of antibiotic is adjusted in accordance with the microbiology report when available)

Arms, Groups and Cohorts

  • Experimental: Lavage arm
    • Intravenous vancomycin & gentamicin with adjunctive lavage
  • Active Comparator: Standard treatment arm
    • Intraperitoneal vancomycin & gentamicin

Clinical Trial Outcome Measures

Primary Measures

  • Peritoneal dialysate effluent (PDE) white cell count and bacterial culture
    • Time Frame: PDE is monitored every 48 hours, until white cell count <100/mm3 and bacterial culture is negative; assessed up to 3 weeks
  • Number of participants requiring Tenckhoff catheter removal
    • Time Frame: Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment

Secondary Measures

  • Number of participants developing relapsing peritonitis
    • Time Frame: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment
  • Number of participants requiring hospitalization
    • Time Frame: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment

Participating in This Clinical Trial

Inclusion Criteria

  • Prevalent PD patients with age >= 18 years old suffering from PD peritonitis – PD effluent white cell count >1090/mm2 on peritonitis day 3 – Lack of clinical response – Informed consent available Exclusion Criteria:

  • PD peritonitis in association with exit site or tunnel infection – Relapsing peritonitis (i.e. peritonitis caused by same organism within 4 weeks after completion of antibiotics therapy) – Fungal peritonitis – Mycobacterial peritonitis (both tuberculosis and non-tuberculosis species) – Clinical suspicion of surgical peritonitis – Penicillin- or cephalosporin allergy, that cefazolin and ceftazidime could not be used

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alice Ho Miu Ling Nethersole Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steve Siu-Man Wong, Associate Consultant – Alice Ho Miu Ling Nethersole Hospital
  • Overall Official(s)
    • Siu-Man Wong, MBChB, FRCPC, Principal Investigator, Alice Ho Miu Ling Nethersole Hospital

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