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Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis

Primary Purpose

Peritoneal Dialysis-associated Peritonitis

Status
Withdrawn
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
Cefazolin
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Dialysis-associated Peritonitis focused on measuring end stage renal disease, infection, antibiotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • peritonitis episodes caused by CNSS, Streptococcal species, or negative bacterial culture

Exclusion Criteria:

  • relapsing peritonitis episodes
  • episodes that do not show a clinical response after 5 days of antibiotic therapy
  • patients who have difficulty in adhering to the antibiotic therapy

Sites / Locations

  • Department of Medicine & Therapeutics, Prince of Wales Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Extended Group

Conventional Group

Arm Description

3 weeks of antibiotics

2 weeks of antibiotics

Outcomes

Primary Outcome Measures

complete cure
survival without relapsing, recurrent, or repeat peritonitis episodes

Secondary Outcome Measures

Full Information

First Posted
September 17, 2018
Last Updated
November 11, 2019
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03675854
Brief Title
Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis
Official Title
Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Withdrawn
Why Stopped
New data from another study show that a positive result is unlikely.
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Background According to the International Society for Peritoneal Dialysis (ISPD) recommendations, "low-risk" peritoneal dialysis (PD)- related peritonitis caused by coagulase-negative staphylococcal species, Streptococcal species, or negative bacterial culture should receive antibiotics for 2 weeks. However, relapsing, recurrent, or repeated episodes are common. Objectives To compare the incidence of relapsing, recurrent, and repeat peritonitis with a 3-week course, as compared to the conventional 2-week course, antibiotic for PD-related peritonitis. Hypothesis Treatment of low-risk PD-related peritonitis for 3 weeks reduces the incidence of relapsing, recurrent, and repeat peritonitis. Design and subjects Randomized control trial of 310 episodes of "low-risk" PD-related peritonitis. Study instruments and interventions Patients will be randomized to receive treatment of the effective antibiotic according to the ISPD recommendations for 2 weeks (Conventional Group) or 3 weeks (Extended Group). All patients will be followed for 6 months after completion of treatment. Main outcome measures Complete cure of the peritonitis episode, defined as survival for 6 months without relapsing, recurrent, or repeat peritonitis episodes. Data analysis Data will be analyzed by both intention-to-treat and per protocol approach. The incidences of complete cure, relapsing, recurrent, and repeated peritonitis episodes will be compared. Expected results Based on our pilot study, we expect to find a significantly lower rate of relapsing, recurrent, and repeated peritonitis episodes in the Extended Group. By proving that "low-risk" peritonitis episodes require 3-week course of antibiotic therapy, our result will change the current recommendation and make treatment for 3 weeks course the standard of care.
Detailed Description
Background According to the International Society for Peritoneal Dialysis (ISPD) recommendations, "low-risk" peritoneal dialysis (PD)- related peritonitis caused by coagulase-negative staphylococcal species, Streptococcal species, or negative bacterial culture should receive antibiotics for 2 weeks. However, relapsing, recurrent, or repeated episodes are common. Objectives To compare the incidence of relapsing, recurrent, and repeat peritonitis with a 3-week course, as compared to the conventional 2-week course, antibiotic for PD-related peritonitis. Hypothesis Treatment of low-risk PD-related peritonitis for 3 weeks reduces the incidence of relapsing, recurrent, and repeat peritonitis. Design and subjects Randomized control trial of 310 episodes of "low-risk" PD-related peritonitis. Study instruments and interventions Patients will be randomized to receive treatment of the effective antibiotic according to the ISPD recommendations for 2 weeks (Conventional Group) or 3 weeks (Extended Group). All patients will be followed for 6 months after completion of treatment. Main outcome measures Complete cure of the peritonitis episode, defined as survival for 6 months without relapsing, recurrent, or repeat peritonitis episodes. Data analysis Data will be analyzed by both intention-to-treat and per protocol approach. The incidences of complete cure, relapsing, recurrent, and repeated peritonitis episodes will be compared. Expected results Based on our pilot study, we expect to find a significantly lower rate of relapsing, recurrent, and repeated peritonitis episodes in the Extended Group. By proving that "low-risk" peritonitis episodes require 3-week course of antibiotic therapy, our result will change the current recommendation and make treatment for 3 weeks course the standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Dialysis-associated Peritonitis
Keywords
end stage renal disease, infection, antibiotic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Extended Group
Arm Type
Experimental
Arm Description
3 weeks of antibiotics
Arm Title
Conventional Group
Arm Type
Active Comparator
Arm Description
2 weeks of antibiotics
Intervention Type
Drug
Intervention Name(s)
Cefazolin
Intervention Description
3 weeks
Primary Outcome Measure Information:
Title
complete cure
Description
survival without relapsing, recurrent, or repeat peritonitis episodes
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: peritonitis episodes caused by CNSS, Streptococcal species, or negative bacterial culture Exclusion Criteria: relapsing peritonitis episodes episodes that do not show a clinical response after 5 days of antibiotic therapy patients who have difficulty in adhering to the antibiotic therapy
Facility Information:
Facility Name
Department of Medicine & Therapeutics, Prince of Wales Hospital
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis

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