Peritoneal Dialysis-associated Peritonitis Clinical Trial
Official title:
Defining the Optimal Duration of Treatment for "Low-Risk" Peritoneal Dialysis-Related Peritonitis
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.
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.
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