Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

IV Antibiotics With Lavage for Severe PD Peritonitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02926846
Recruitment Status : Completed
First Posted : October 6, 2016
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peritonitis Kidney Failure Drug: Intravenous vancomycin & gentamicin with adjunctive lavage Drug: Intraperitoneal vancomycin & gentamicin Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial on Intravenous Antibiotics With Adjunctive Lavage for Severe Peritoneal-dialysis Related Peritonitis
Study Start Date : March 2014
Actual Primary Completion Date : November 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Dialysis

Arm Intervention/treatment
Experimental: Lavage arm
Intravenous vancomycin & gentamicin with adjunctive lavage
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)


Active Comparator: Standard treatment arm
Intraperitoneal vancomycin & gentamicin
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)





Primary Outcome Measures :
  1. 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 ]
  2. 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 Outcome Measures :
  1. Number of participants developing relapsing peritonitis [ Time Frame: All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment ]
  2. Number of participants requiring hospitalization [ Time Frame: All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926846


Locations
Layout table for location information
Hong Kong
Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
Alice Ho Miu Ling Nethersole Hospital
Investigators
Layout table for investigator information
Principal Investigator: Siu-Man Wong, MBChB, FRCPC Alice Ho Miu Ling Nethersole Hospital

Layout table for additonal information
Responsible Party: Steve Siu-Man Wong, Associate Consultant, Alice Ho Miu Ling Nethersole Hospital
ClinicalTrials.gov Identifier: NCT02926846    
Other Study ID Numbers: 2013.201
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Steve Siu-Man Wong, Alice Ho Miu Ling Nethersole Hospital:
Peritoneal dialysis
Lavage
Additional relevant MeSH terms:
Layout table for MeSH terms
Peritonitis
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Vancomycin
Gentamicins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action