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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03675854

Collaborator

(none)

Enrollment

Location

Arms

8.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peritoneal Dialysis-associated Peritonitis	Drug: Cefazolin	Phase 4

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Sep 30, 2019

Actual Study Completion Date :

Sep 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extended Group 3 weeks of antibiotics	Drug: Cefazolin 3 weeks
Active Comparator: Conventional Group 2 weeks of antibiotics	Drug: Cefazolin 3 weeks

Arm

Intervention/Treatment

Experimental: Extended Group

3 weeks of antibiotics

Drug: Cefazolin

3 weeks

Active Comparator: Conventional Group

2 weeks of antibiotics

Drug: Cefazolin

3 weeks

Outcome Measures

Primary Outcome Measures

complete cure [6 months]
survival without relapsing, recurrent, or repeat peritonitis episodes

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cheuk-Chun SZETO, Professor, Department of Medicine & Therapeutics, Chinese University of Hong Kong

ClinicalTrials.gov Identifier:

NCT03675854

Other Study ID Numbers:

CREC-2018.245-T

First Posted:

Sep 18, 2018

Last Update Posted:

Nov 13, 2019

Last Verified:

Nov 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cheuk-Chun SZETO, Professor, Department of Medicine & Therapeutics, Chinese University of Hong Kong

end stage renal disease

infection

antibiotic

Additional relevant MeSH terms:

Peritonitis

Cefazolin

Study Results

No Results Posted as of Nov 13, 2019