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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 80
- Primary Endpoint
- Complete Cure Rate
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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.
Intervention: vancomycin (Drug)
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.
Intervention: ceftazidime (Drug)
study group
IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
Intervention: vancomycin (Drug)
study group
IP vancomycin 1g every 5 days combined with oral moxifloxacin 400mg QD. The duration of treatment was based on ISPD guideline recommendations.
Intervention: moxifloxacin (Drug)
Outcomes
Primary Outcomes
Complete Cure Rate
Time Frame: 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 Outcomes
- Primary Response Rate(on day 10 by using antibiotics alone)
- Primary Treatment Failure Rate(after 3 days of treatment by the assigned antibiotics)
- Secondary Treatment Failure Rate(after 6 to 8 days of treatment)
Investigators
Dong Jie
Professor
Peking University First Hospital