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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03675854
Recruitment Status : Withdrawn (New data from another study show that a positive result is unlikely.)
First Posted : September 18, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Cheuk-Chun SZETO, Chinese University of Hong Kong

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:

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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Study Type : Interventional  (Clinical Trial)
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 : January 1, 2019
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

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




Primary Outcome Measures :
  1. complete cure [ Time Frame: 6 months ]
    survival without relapsing, recurrent, or repeat peritonitis episodes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03675854


Locations
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Hong Kong
Department of Medicine & Therapeutics, Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
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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: September 18, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:
end stage renal disease
infection
antibiotic
Additional relevant MeSH terms:
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Peritonitis
Intraabdominal Infections
Infection
Peritoneal Diseases
Digestive System Diseases
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents