Peritoneal Dialysis Associated Peritonitis
Conditions
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.
Interventions
DRUGvancomycin
IP vancomycin 1g every 5 days
DRUGmoxifloxacin
oral moxifloxacin 400mg QD
DRUGceftazidime
IP ceftazidime 1g QD
Sponsors
Peking University First Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Cure Rate | within 4 weeks of completion of therapy | 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
| Measure | Time frame | Description |
|---|---|---|
| Primary Response Rate | on day 10 by using antibiotics alone | 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 | after 3 days of treatment by the assigned antibiotics | 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 | after 6 to 8 days of treatment | 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 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group 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 | 40 |
| Study Group 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 | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 13 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 27 Participants | 55 Participants |
| Age, Continuous | 57.2 years STANDARD_DEVIATION 13 | 58.0 years STANDARD_DEVIATION 15.7 | 57.6 years STANDARD_DEVIATION 14.4 |
| Region of Enrollment China | 40 participants | 40 participants | 80 participants |
| Sex: Female, Male Female | 15 Participants | 16 Participants | 31 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 40 | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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
Time frame: within 4 weeks of completion of therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Complete Cure Rate | 32 Participants |
| Study Group | Complete Cure Rate | 31 Participants |
Secondary
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
Time frame: on day 10 by using antibiotics alone
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Primary Response Rate | 32 Participants |
| Study Group | Primary Response Rate | 27 Participants |
Secondary
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
Time frame: after 3 days of treatment by the assigned antibiotics
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Primary Treatment Failure Rate | 8 Participants |
| Study Group | Primary Treatment Failure Rate | 13 Participants |
Secondary
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
Time frame: after 6 to 8 days of treatment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Secondary Treatment Failure Rate | 5 Participants |
| Study Group | Secondary Treatment Failure Rate | 4 Participants |