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

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ClinicalTrials.gov Identifier: NCT02787057
Recruitment Status : Completed
First Posted : June 1, 2016
Results First Posted : March 26, 2020
Last Update Posted : March 26, 2020
Sponsor:
Information provided by (Responsible Party):
Dong Jie, Peking University First Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Peritoneal Dialysis Associated Peritonitis
Interventions Drug: vancomycin
Drug: moxifloxacin
Drug: ceftazidime
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Study Group
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

Period Title: Overall Study
Started 40 40
Completed 40 40
Not Completed 0 0
Arm/Group Title Control Group Study Group Total
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
27
  67.5%
28
  70.0%
55
  68.8%
>=65 years
13
  32.5%
12
  30.0%
25
  31.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
58.0  (15.7) 57.2  (13.0) 57.6  (14.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
16
  40.0%
15
  37.5%
31
  38.8%
Male
24
  60.0%
25
  62.5%
49
  61.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 40 participants 40 participants 80 participants
40 40 80
1.Primary Outcome
Title Complete Cure Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Study Group
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
32
  80.0%
31
  77.5%
2.Secondary Outcome
Title Primary Response Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Study Group
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
32
  80.0%
27
  67.5%
3.Secondary Outcome
Title Primary Treatment Failure Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Study Group
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
8
  20.0%
13
  32.5%
4.Secondary Outcome
Title Secondary Treatment Failure Rate
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group Study Group
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

Overall Number of Participants Analyzed 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
5
  12.5%
4
  10.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group Study Group
Hide Arm/Group 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.

vancomycin: IP vancomycin 1g every 5 days

ceftazidime: IP ceftazidime 1g QD

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

vancomycin: IP vancomycin 1g every 5 days

moxifloxacin: oral moxifloxacin 400mg QD

All-Cause Mortality
Control Group Study Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Control Group Study Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/40 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2.5%
Control Group Study Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/40 (2.50%)      1/40 (2.50%)    
Gastrointestinal disorders     
nausea   0/40 (0.00%)  0 1/40 (2.50%)  1
Skin and subcutaneous tissue disorders     
rash   1/40 (2.50%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jie Dong
Organization: Peking University First Hospital
Phone: +86 010 66551708
EMail: jie.dong@bjmu.edu.cn
Layout table for additonal information
Responsible Party: Dong Jie, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02787057    
Other Study ID Numbers: empirical schemes
First Submitted: May 23, 2016
First Posted: June 1, 2016
Results First Submitted: March 11, 2020
Results First Posted: March 26, 2020
Last Update Posted: March 26, 2020