Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Peritoneal Dialysis-associated Peritonitis
  • Peritonitis

NCT number NCT03675854
Study type Interventional
Source Chinese University of Hong Kong
Contact
Status Withdrawn
Phase Phase 4
Start date January 1, 2019
Completion date September 30, 2019

See also
  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 NCT05971537 - Clinical Trial on Antibiotic-Lock in Tenckhoff Catheter for Relasping and Repeat Peritonitis Phase 4
Recruiting NCT05860270 - Oral Vitamin D Supplementation Prevent Peritoneal Dialysis-related 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