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Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis (PD)

Primary Purpose

Peritoneal Dialysis Associated Peritonitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
vancomycin
moxifloxacin
ceftazidime
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peritoneal Dialysis Associated Peritonitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • incident or prevalent peritoneal dialysis patients
  • diagnosis of acute peritonitis according to ISPD guideline
  • age >18 years

Exclusion Criteria:

  • receiving antibiotic treatment for other reasons when peritonitis occurred
  • contraindication to cephalosporin, vancomycin, or fluoroquinolones
  • concomitant exit-site or tunnel infection
  • requirement for immediate transfer to hemodialysis due to sepsis, gastrointestinal perforation or visceral inflammation, severe bowel obstruction, or ultrafiltration failure at the initiation of peritonitis
  • inability to tolerate oral administration due to severe gastrointestinal complication or other reasons
  • history of psychological illness or condition which interfered with ability to understand or comply with the requirements of the study
  • pregnant or breast-feeding

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Control group

    study group

    Arm Description

    IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.

    IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.

    Outcomes

    Primary Outcome Measures

    Complete Cure Rate
    complete cure was defined as complete resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) by using antibiotics alone without relapse within 4 weeks of completion of therapy

    Secondary Outcome Measures

    Primary Response Rate
    Primary response was defined as resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) on day 10 by using antibiotics alone
    Primary Treatment Failure Rate
    Primary treatment failure was defined as the presence of fever, abdominal pain, and turbid peritoneal dialysate, and if the total peritoneal WBC counts is >50% of the pretreatment values after 3 days of treatment by the assigned antibiotics
    Secondary Treatment Failure Rate
    Secondary treatment failure was defined as treatment failure despite adjustment of antibiotics or changing to second line antibiotics for 3 to 5 days in patients with primary treatment failure

    Full Information

    First Posted
    May 23, 2016
    Last Updated
    March 11, 2020
    Sponsor
    Peking University First Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02787057
    Brief Title
    Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis
    Acronym
    PD
    Official Title
    Intraperitoneal (IP) Vancomycin Plus Oral Moxifloxacin Versus IP Vancomycin Plus IP Ceftazidime for the Treatment of Peritoneal Dialysis-related Peritonitis: a Pilot Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2012 (undefined)
    Primary Completion Date
    April 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University First Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Intra-peritoneal administration of antibiotics covering both gram-positive and gram-negative organisms was recommended as first-line regimen for the management of peritoneal dialysis related peritonitis. Oral administration of quinolones can also achieve effective serum concentrations, and is more convenient and economical. We conducted a pilot randomized controlled study to compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime.
    Detailed Description
    To compare the effects on peritonitis cure and relapsing rates between oral moxifloxacin plus IP vancomycin and conventional IP vancomycin plus ceftazidime, eligible PD patients were randomly assigned to study group (IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD) and control group (IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD). Patients were followed for 3 months after the completion of the treatment period. Primary endpoint is complete cure, secondary endpoint are primary response and primary or secondary treatment failure.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peritoneal Dialysis Associated Peritonitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    Experimental
    Arm Description
    IP vancomycin 1g every 5 days combined with IP ceftazidime 1g QD. The duration of treatment was based on internatinal society of peritoneal dialysis (ISPD) guideline recommendations.
    Arm Title
    study group
    Arm Type
    Active Comparator
    Arm Description
    IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
    Intervention Type
    Drug
    Intervention Name(s)
    vancomycin
    Intervention Description
    IP vancomycin 1g every 5 days
    Intervention Type
    Drug
    Intervention Name(s)
    moxifloxacin
    Intervention Description
    oral moxifloxacin 400mg QD
    Intervention Type
    Drug
    Intervention Name(s)
    ceftazidime
    Intervention Description
    IP ceftazidime 1g QD
    Primary Outcome Measure Information:
    Title
    Complete Cure Rate
    Description
    complete cure was defined as complete resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) by using antibiotics alone without relapse within 4 weeks of completion of therapy
    Time Frame
    within 4 weeks of completion of therapy
    Secondary Outcome Measure Information:
    Title
    Primary Response Rate
    Description
    Primary response was defined as resolution of peritonitis (normalization of body temperature, resolution of abdominal pain, clearing of dialysate, and PD effluent neutrophil count less than 100 cells/mL and proportion of polynuclear cell less than 50%) on day 10 by using antibiotics alone
    Time Frame
    on day 10 by using antibiotics alone
    Title
    Primary Treatment Failure Rate
    Description
    Primary treatment failure was defined as the presence of fever, abdominal pain, and turbid peritoneal dialysate, and if the total peritoneal WBC counts is >50% of the pretreatment values after 3 days of treatment by the assigned antibiotics
    Time Frame
    after 3 days of treatment by the assigned antibiotics
    Title
    Secondary Treatment Failure Rate
    Description
    Secondary treatment failure was defined as treatment failure despite adjustment of antibiotics or changing to second line antibiotics for 3 to 5 days in patients with primary treatment failure
    Time Frame
    after 6 to 8 days of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: incident or prevalent peritoneal dialysis patients diagnosis of acute peritonitis according to ISPD guideline age >18 years Exclusion Criteria: receiving antibiotic treatment for other reasons when peritonitis occurred contraindication to cephalosporin, vancomycin, or fluoroquinolones concomitant exit-site or tunnel infection requirement for immediate transfer to hemodialysis due to sepsis, gastrointestinal perforation or visceral inflammation, severe bowel obstruction, or ultrafiltration failure at the initiation of peritonitis inability to tolerate oral administration due to severe gastrointestinal complication or other reasons history of psychological illness or condition which interfered with ability to understand or comply with the requirements of the study pregnant or breast-feeding

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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