Peritoneal Dialysis-associated Peritonitis Clinical Trial
Official title:
Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis
Verified date | November 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Department of Medicine & Therapeutics, Prince of Wales Hospital | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | complete cure | survival without relapsing, recurrent, or repeat peritonitis episodes | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03264625 -
The Effects of Oral Vitamin D Supplementation on the Prevention of Peritoneal Dialysis-related Peritonitis
|
Phase 2 | |
Suspended |
NCT05300191 -
In Vitro Analysis of Effluent Dialysate Solution From Patients on Peritoneal Dialysis, With the CloudCath Device
|
||
Completed |
NCT03685747 -
Vancomycin Pharmacokinetics in Patients on Peritoneal Dialysis
|
Phase 1 | |
Recruiting |
NCT03046511 -
Peritonitis Prevention After Insertion of Peritoneal Dialysis Catheter.
|
Phase 3 | |
Recruiting |
NCT05285436 -
A Prospective Clinical Study to Assess the Clinical Utility of Turbidity in Patients Using In-Home Peritoneal Dialysis
|
N/A | |
Recruiting |
NCT05860270 -
Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related Peritonitis
|
Phase 4 | |
Recruiting |
NCT05971537 -
Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis
|
Phase 4 | |
Completed |
NCT01293799 -
Prevention of Peritonitis in Peritoneal Dialysis
|
N/A | |
Completed |
NCT05450523 -
Neutrophil Gelatinase-Associated Lipocalin (NGAL) Rapid Test (Colloidal Gold) Clinical Trial Protocol
|
||
Terminated |
NCT00801775 -
Improved Diagnosis of Peritoneal Dialysis Peritonitis by Calorimetry
|
N/A | |
Completed |
NCT04515498 -
A Prospective Clinical Study of the CloudCath System During In-home Peritoneal Dialysis
|