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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03675854
Enrollment
0
Registered
2018-09-18
Start date
2019-01-01
Completion date
2019-09-30
Last updated
2019-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis-associated Peritonitis

Keywords

end stage renal disease, infection, antibiotic

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.

Interventions

DRUGCefazolin

3 weeks

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complete cure6 monthssurvival without relapsing, recurrent, or repeat peritonitis episodes

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026