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
About this trial
This is an interventional treatment trial for Peritoneal Dialysis Associated Peritonitis
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
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
NCT ID
NCT02787057
First Posted
May 23, 2016
Last Updated
March 11, 2020
Sponsor
Peking University First Hospital
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
Vancomycin Plus Moxifloxacin Versus Vancomycin Plus Ceftazidime for the Treatment of Peritoneal Dialysis (PD)-Related Peritonitis
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