NCT02926846

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

3.7 years

First QC Date

October 1, 2016

Last Update Submit

January 29, 2018

Conditions

PeritonitisKidney Failure

Keywords

Peritoneal dialysisLavage

Outcome Measures

Primary Outcomes (2)

  • Peritoneal dialysate effluent (PDE) white cell count and bacterial culture

    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

    Tenckhoff catheter removal is arranged when there is no clinical response after 5 days of treatment

Secondary Outcomes (2)

  • Number of participants developing relapsing peritonitis

    All participants are observed for any peritonitis within 4 weeks of completion of antibiotics treatment

  • Number of participants requiring hospitalization

    All participants are observed for any hospitalization within 12 weeks of completion of antibiotics treatment

Study Arms (2)

Lavage arm

EXPERIMENTAL

Intravenous vancomycin \& gentamicin with adjunctive lavage

Drug: Intravenous vancomycin & gentamicin with adjunctive lavage

Standard treatment arm

ACTIVE COMPARATOR

Intraperitoneal vancomycin \& gentamicin

Drug: Intraperitoneal vancomycin & gentamicin

Interventions

Intravenous vancomycin & gentamicin with adjunctive lavageDRUG

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)

Lavage arm
Intraperitoneal vancomycin & gentamicinDRUG

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)

Standard treatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

PeritonitisRenal Insufficiency

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Siu-Man Wong, MBChB, FRCPC

    Alice Ho Miu Ling Nethersole Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Consultant

Study Record Dates

First Submitted

October 1, 2016

First Posted

October 6, 2016

Study Start

March 1, 2014

Primary Completion

November 1, 2017

Study Completion

January 1, 2018

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

HK(1)